The pharmaceutically effective component of a drug (also API)
An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information.
Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence); to combine the proper self-administration of treatment with a patient's sticking with it.
"The definition of ""adverse event"" for both prescription drugs and dietary supplements is ""any health-related event associated with the use of a that is adverse"". This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.
FDA defines an Adverse drug experience as ""Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action."" "
"FDA requires manufacturers, packers, and distributors of marketed prescription drug products to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Pharma companies must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.
FDA law requires pharmaceutical companies to periodically report any adevrse events it has knowledge of. Before considering any clinical incident for submission to the FDA in an expedited or periodic safety report, applicants, manufacturers, and licensed manufacturers should have knowledge of the following four dats elements:
An identifiable patient; And identifiable reporter; A suspect drug, biological product, or device; and An adverse event or fatal outcome.
According to the FDA, ""Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations"" (see ""Adverse Event Reporting System (AERS)"")."
Permission under drug laws to market a drug in a national market.
On the pharmaceutical market: control of equipment and documentation of manufacturers or their suppliers
Relating to a stage in a patient's behaviorial progression with regard to a medical condition in which the patient is just finding out about the condition and whether it pertains to him or her.
Addiction recovery programs often refer to three stages of behavior leading to recovery: Awareness, Acceptance, and Action. This progression may be called "The Three A's" and is used as a tool to help people come to terms with their addiction.
The same behaviorial progression is seen with patients coming to terms with a chronic medical condition.
Patients need different information from prospects and marketing messages need to change as prospects go through the behavioral progression starting at Awareness (just finding out about the condition and whether it pertains to them), moving to Acceptance (the potential risk has been personalized and the prospect is considering seeking information and/or evaluation), and finally arriving at Action (ready to talk with physician about treatment or is already on therapy).
Pharmaceutical marketers often use the term "Disease Awareness" and try to increase the market size of a therapeutic area by using DTC advertising and physician marketing to "build" awareness of a particular medical condition. An example would be ads for "overactive bladder," which have been successful in building awareness among consumers of a medical condition (urinary incontinence or urgency) that many thought was only of concern for senior citizens.
The Federal Institute for Drugs and Medical Products, the German federal regulatory authority charged with evaluating and approving drugs and medical products.
Comparison of blood levels between drugs with identical active ingredients, e.g. generics and initial supplier products
Drugs in protein form produced biopharmaceutically, i.e. by means of genetically modified cell lines. In the EU, biopharmaceuticals are always subject to a central approval procedure.
Clinical study on health test subjects to prove the bioequivalence of drugs having identical active ingredients.
Text called out in a drug's prescribing information indicating that medical studies show that the drug carries a significant risk of serious or even life-threatening adverse effects. The strongest warning the FDA requires, it is so named for the black border that surrounds the text. Also called black label warning or boxed warning.
Federal Ministry of Health and Social Security in Germany
FDA has from time to time seen manufacturers use "bookend" advertisements in print or broadcast formats. These advertisements consist of two parts: (1) a "reminder" advertisement, which includes the name of a drug or device but makes no safety or effectiveness claims; and (2) a disease awareness message encouraging consumers to seek health care practitioner assistance in identifying and treating a particular health condition but does not mention any product by name. Neither component alone would be subject to FDA rules for requiring risk disclosure. But taken together, FDA is concerned that they are understood by consumers as product claim advertisements, without the inclusion of proper disclosure of required risk information.
The draft guidance therefore provides advice to manufacturers on the criteria FDA uses in determining whether bookend advertisements are subject to regulation as product claim advertisements. The criteria, in brief, are whether the two components are perceptually distinct and whether they are separated in space or time. FDA requests comment on these two criteria.
FDA may treat ads as labeling or advertising: "when the communication is presented in combination with reminder promotion or product claim promotion in a way that causes the audience to perceive the two pieces as one advertisement or promotional labeling piece."
The name commonly used in advertising (for example, Viagra, Celebrex, or Ambien); also called the proprietary name.
The American Marketing Association defines a brand as "a name, term, design, symbol, or any other feature that identifies one seller's good or service as distinct from those of other sellers." Walter Landor, who helped create and develop such famous brands as Coca-Cola, defined a brand as a "promise." "By identifying and authenticating a product or service, it delivers a pledge of satisfaction and quality."
Brand marketing focuses on communicating the brand message to drive awareness and affect attitude.
In the health care market: drugs, medical, or health care products sold under a product-specific brand name.
In a prescription drug ad, a true statement of information relating to the side effects, contraindications, and effectiveness of the drug. .Required by the Federal Food, Drug, and Cosmetic Act (FDCA).
A shortened version of a drug’s full prescribing information. The brief summary includes all the risk information about the drug but may omit non-risk information, such as chemical composition and directions for use. Print ads making claims about a drug must include the indication and brief summary, which usually appears on its own page. Also called the brief summary of prescribing information.
Section of the FDA that ensures drugs made available to the public are safe and effective. CDER regulates over-the-counter and prescription drugs, including generics, as well as products like toothpaste, deodorant, and sunscreen.
European approval procedure, carried out by the EMEA which is compulsory for new drugs and active ingredients in the field of biotechnology, that may lead to Europe-wide approval.
Purchase and subsequent sale of third-party products; in the pharmaceutical market this frequently refers to wholesale business or parallel imports.
Provide inventors or companies with protection against competition for an invention for a limited time period. The best-known commercial property right is the patent. In addition, SPCs play an important role in the pharmaceutical market.
The department of the European Medicines Agency that assesses a drug for marketing approval for quality, safety, and efficacy based on the review of scientific data. CHMP recommends the content needed for a drug’s summary of product characteristics, labeling, and packaging requirements.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."
Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.
"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
Percent of doses of a drug taken as prescribed while patient is actively taking drug.
The Accreditation Council for Continuing Medical Education's (ACCME') definition of CME describes what content is acceptable for activities that are certified for credit:
Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.
A broad definition of CME, such as the one found above, recognizes that all continuing educational activities which assist physicians in carrying out their professional responsibilities more effectively and efficiently are CME. A course in management would be appropriate CME for physicians responsible for managing a health care facility; a course in educational methodology would be appropriate CME for physicians teaching in a medical school; a course in practice management would be appropriate CME for practitioners interested in providing better service to patients.
Not all continuing educational activities which physicians may engage in however are CME. Physicians may participate in worthwhile continuing educational activities which are not related directly to their professional work and these activities are not CME. Continuing educational activities which respond to a physician's non-professional educational need or interest, such as personal financial planning or appreciation of literature or music, are not CME.
CME that discusses issues related to coding and reimbursement in a medical practice falls within ACCME's definition of CME.
All CME educational activities developed and presented by a provider accredited by the ACCME system and associated with AMA PRA Category 1 Credit™ must be developed and presented in compliance with all ACCME accreditation requirements -- in addition to all the requirements of the AMA PRA program. All activities so designated for, or awarded, credit will be subject to review by the ACCME accreditation process as verification of fulfillment of the ACCME accreditation requirements.
A situation in which a medication should not be used (for example, in patients with medical conditions such as kidney problems or allergies)
The patient's own share of payment for services to public health care system.
The person or institution bearing costs of a drug.
Prior to the end of this period, a second supplier taking part in an EU approval process may not use documentation that was submitted by the initial supplier regarding the efficacy and safety of an active ingredient.
New EU approval procedure, possible since November 2005, that represents an alternative to the MR procedure. In contrast to the MR procedure, the new procedure allows an applicant for an approval for a pharmaceutical product to submit an application in several European countries at the same time, without the need to have an existing approval in one EU country.
The detail aid -- also known as a sales aid or visual aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The detail aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.
A detail aid usually is composed of information about the product's efficacy, clinical data that support the manufacturer's claims, charts and graphs, guidance for dosing and administration of the drug, and summary information pertaining to the product's tolerability and safety. It may also include the official labeling. The detail ad is primarily a marketing tool that incorporates creative elements such as photos, slogans, and brand logos .
Detailing refers to the activity of pharmaceutical sales representatives (reps) when they make calls to physicians and provide them with "details" -- approved scientific information, benefits, side effects, or adverse events -- related to a drug. Pharmasales reps were once called "detail men." These days, however, sales reps are as likely to be women as men.
Extracorporeal blood cleansing for patients with kidney failure.
This law, enacted in the late 1990s, exempts herbal supplements and vitamins from the regulations covering supplements may suggest therapeutic beneﬁ ts without clinical trials and are not required to disclose safety, side effects, or contraindications.
Direct marketing is broadly defined by the Direct Marketing Association as "any direct communication to a consumer or business recipient that is designed to generate a response in the form of an order (direct order), a request for further information (lead generation), and/or visit to a store or other place of business for purchase of a specific product or service (traffic generation)."
Direct marketing differs from traditional brand marketing in that the goal of the latter is to build awareness and affect attitude, whereas the goal of direct marketing is to achieve two-way dialogue with the prospect and affect behavior.
The promotion of prescription drugs by pharmaceutical companies directly to consumers via broadcast and print media such as television, radio, magazines, billboards, and also the Internet.
Advertisements for prescription drugs that appear in the general media (television, radio, magazines, the Internet) and are targeted at the general public rather than healthcare providers such as doctors, nurses, and pharmacists.
Pharmaceutical marketers often use the term "Disease Awareness" in reference to Help-Seeking Ads. These ads are designed to increase the market size of a therapeutic by "building" awareness of a particular medical condition. An example would be ads for "overactive bladder," which have been successful in building awareness among consumers of a medical condition (urinary incontinence or urgency) that many thought was only of concern for senior citizens.
Disease awareness communications are communications disseminated to health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or medical device or make any representation or suggestion concerning a particular drug or medical device. Help-seeking communications are disease awareness communications directed at consumers. Generally, help-seeking and other disease awareness communications do not constitute labeling or advertising, and therefore are not subject to regulation by FDA. The Agency believes that such communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment.
Disease mongering is a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them.
Division of the FDA’s Center for Drug Evaluation and Research that reviews promotional material for prescription drug advertising and labeling information to ensure that it is not false or misleading and adheres to FDA-mandated regulatory requirements.
Form in which an active pharmaceutical ingredient has been produced by pharmaceutical manufacturing and in which it is administered to the patient, e.g. tablets, capsules, drops etc.
Documentation required in an application for drug approval that describes the quality, safety, and efficacy of that drug.
According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor.
According to the Prescription Project: Samples serve two distinct marketing purposes. (1) Physicians value samples and are willing to spend time with sales representatives to get them. (2) Secondly, samples serve as "starter" medications -- an enticement to prescribe new, heavily marketed and generally more expensive medications. Once therapy has been initiated, patients and their insurers are likely to continue to pay for the new, costly drugs.
Early product launch of a first generic with approval of the initial supplier before expiration of relevant commercial property rights
eDetailing is often used as a blanket term for various online physician marketing, promotional and communication activities.
Virtual Details - Web or CD-based self-guided informational programs with no live communication
Video Details - Online, live, or phone assisted browsing through virtual sales presentations
Other activities - Electronically enabled promotional, educational or service efforts
Online Events - Online seminar, CME event, opinion leader event, or web conference
An online database of information about prescription medicines licensed for marketing in the European Union. The EMC houses current versions of a drug’s summary of product characteristics and patient information leaﬂet.
European Medicine Evaluation Agency, central EU authority for drug evaluation and approval.
Electronic prescribing, as defined by the National Council for Prescription Drug Programs (NCPDP), a standards development organization, has two parts:
Part 1: Two way [electronic] communication between physicians and pharmacies involving new prescriptions, refill authorizations, change requests, cancel prescriptions, and prescription fill messages to track patient compliance. Electronic Prescribing is not Faxing or printing paper prescriptions.
Part 2: Potential for information sharing with other health care partners including eligibility/formulary information and medication History
Biopharmaceutical active ingredient in protein form, which is produced by living cell lines. Depending on the individual cell lines used and the production process associated with it, so-called glyco structures (oligosaccharide chains) can differ minimally. Epo-alpha and Epo-beta have been launched on the market among others; the Erythropoietin biosimilar being developed by BIOCEUTICALS is Epo-zeta. Erythropoietin is used, among other things, in nephrology for dialysis patients to stimulate hematopoieses as well as in cancer therapy
Electronic Sampling uses online tools/promotinal websites accessed by physicians to collect the details of sample distribution. It provides pharmaceutical companies with a cost-effective way to reach physicians who have been routinely under-covered by sales representatives.It allows manufacturers to meet increasingly challenging sales and marketing goals by reducing the significant costs associated with the traditional sample distribution process.
The law stating that any promotional material making claims about a drug’s beneﬁts be fairly balanced with information about its risks, in both content (warnings, side effects, contraindications) and presentation (proximity to claims, font size, color).
Food and Drug Administration, the approvals, supervisory and monitoring authority of the pharmaceutical market in the U.S.
Biopharmaceutical active ingredient in protein form, which is produced by living cell lines. Filgrastim is used, among other things, in the treatment of a neutropenia, for example following cytotoxic chemotherapy or bone marrow transplants.
Drugs with low potential risk which need not be sold in pharmacies.
The name of the drug’s active ingredient (for example, sildenaﬁ l citrate, celecoxib, or zolpidem tartrate); also called the established name. Note: More than one brand name can be used for the same generic ingredient.
Generics are drugs having the same active ingredient as an initial supplier product and the same therapeutic effect, but that are offered at significantly lower prices than the equivalent drugs of initial suppliers after the expiration of the patent or other applicable commercial property rights
Good Manufacturing Practice international production standard in the pharmaceutical industry.
Products that promote health, but are not considered either drugs or medical products.
Contains strict rules about patient privacy and access to patient prescription and medical information. Any promotional program directed at patients based on their diagnosis or prescription drug history must be HIPAA-compliant.
An ad that calls attention to a condition or set of symptoms without naming a particular drug. Help-seeking ads require no prescribing information or fair balance and may be run by companies that have no currently approved drugs for the named indication. Help-seeking ads are also valuable when only 1 drug is approved for a particular indication.
Diseases for which a certain drug is used.
The disease or condition that a drug is approved by the FDA to treat. While many drugs are approved with a single indication, some drugs may have more than one.
In the pharmaceutical market: the company that first introduces a new, patented, active pharmaceutical ingredient based on the result of research in a national market.
Generics named after the internationally recognized designation for the active ingredient, plus a company-specific suffix.
The process of getting a drug approved by the FDA -- the investigational new drug ("IND") process -- is costly and time-consuming. The IND process typically has three separate phases.
"Phase I" trials, evaluate the safety of the medication by studying the effect of the drug and are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
"Phase II" trials are designed to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition.
"Phase III" trials, are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
Many drugs, like chemotherapy for an example, have deeply deleterious -- sometimes even fatal -- side effects, and part of the FDA approval process is weighing the potentiality for those side effects against the disease process the drug is designed to treat. The sponsor's goal at the end of the IND process is an approved New Drug Application ("NDA").
Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior. Pharmaceutical companies generally engage key opinion leaders early in the drug development process to provide advocacy activity and key marketing feedback.
Term used in the STADA Group for a uniform sales concept for different products.
Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio or visual matter descriptive of a drug and references published (for example, the Physician's Desk Reference) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the FD&C Act.
Permit required under law for the manufacture of drugs; specific facilities and personnel resources and organization of production operations are stipulated.
Professionals (employees of pharmaceutical companies) -- most with advanced medical, pharmacy or science degrees -- that offer credibility and objectivity of a peer, but also provide an insider's knowledge of their companies and products. MSLs coordinate the flow of clinical information and manage important key opinion leader (KOL) relationships, which can be critical to a product's success at any stage of its life cycle.
The FDA's safety information and adverse events reporting program. MedWatch disseminates important product information to healthcare professionals and accepts feedback from consumers and healthcare professionals regarding suspected problems related to a drug. Product claim ads and reminder ads must contain the MedWatch reporting statement.
Monoclonal antibodies are immunologically active proteins which are used against an individual epitope (surface structure) of an antigen (infectious substances or certain molecules) and specifically bind to that substance. Monoclonal antibodies are generated with molecular biological methods and produced biotechnologically through genetically engineered cell lines.
Mutual Recognition Procedure – European approval procedure enabling additional approvals in other EU countries based on the prior existence of national approval of a particular drug. The decentralized approval procedure has been in existence since 2005 as an alternative to the MR procedured.
In the pharmaceutical market: the legal entitlement allowing individuals to own more than one pharmacy so that pharmacy chains can be formed through the combination of minority interests. In Germany, multiple ownership of pharmacies is legally restricted to a maximum of four pharmacies for each pharmacist.
Technical term for products in the health care market, usually drugs, that are available for marketing without the companies having to conduct their own basic research on new active ingredients. The commercial property rights for the active ingredients of multisource products have usually expired. Thus, off-patent active ingredients can as a rule be procured from a variety of raw material suppliers on the world market.
New Drug Application, special FDA approval procedure for drugs with new active ingredients, new active ingredient combinations, new indications or new application methods for active ingredients or drugs already approved in the U.S.
Branch of internal medicine dealing with diagnostics and non-surgical therapy of kidney diseases.
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number. Source: Food and Drug Administration
A New Molecular Entity (NME) or New Chemical Entity (NCE) is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance. Being labeled as entirely 'new' or first-in-class molecule dictates that certain types of clinical trials must be run, and that particular attention must be paid to proving a drugs safety.
In the pharmaceutical market: the legal entitlement allowing non-pharmacists to own pharmacies. In combination with multiple ownership, non-pharmacist ownership enables the creation of chains of pharmacies. Non-pharmacist ownership is not legal in Germany.
FDA defines off label use as, "Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."
"FDA recognizes that off label use of drugs by prescribers is often appropriate and may receive endorsement from published literature; they may also receive recommendations as 'Other standard uses - i.e., recommended by subspecialty societies, CDC, etc.'" Source: FDA.
"An unlabeled use [off-label use] of a drug is a use that is not included as an indication on the drug's label as approved by the FDA." Source: Medicare.
Once a new prescription drug has been approved by the FDA, and prescriptions have been written and used by patients, patients and professionals may discover that there are additional symptoms or conditions the drug may treat effectively that were not among the reasons the drug was originally approved.
Knowing about these different ways the drug may be effective, a doctor may decide to prescribe the drug for one of these alternative reasons. Such a prescription is considered to be "off-label." The drug does not need to go through the FDA process for the off-label prescription.
In particular, generic drugs that have been in use for many years may be discovered to have alternative uses.
In the US, it is legal for doctors to write off-label prescriptions. However, it is not legal for pharmaceutical companies to promote any drugs they manufacture for off-label use. They may promote the use of drugs only for the reasons the drug was approved.
Science that deals with the study of cancer.
A drug for the treatment of a rare disease. In accordance with EU law, orphan drugs must undergo a centralized approval process at the EMEA, the European drug-approval agency. Once approval has been granted, the drugs have guaranteed market exclusivity for at least 6 years.
Market for OTC (over the counter) products, i. e. drugs and medical or health care products that the customer is able to purchase, especially in pharmacies, without a doctor's prescription.
These are OTC drugs that were reimbursed in the past by the public health care system if prescribed by a doctor.
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging, hence "package insert."
Pharmaceutical products are described as parallel import pharmaceuticals when a third party, i.e. a company that is independent of the holder of the approval and/or the manufacturer, acquires them in another EU or EEA member state and imports them to Germany in order to also market them there – parallel to the original pharmaceutical company.
In the pharmaceutical market: commercial property right granting active pharmaceutical ingredients market exclusivity for a limited period (in the EU 20 years for example).
The European Union equivalent of the prescribing information (package insert) in the United States. The Leaflet is included in a medicine's packaging and is a patient-friendly version of the summary of product characteristics.
Number of days from first dose until patient stops taking drug.
Conversion of pharmaceutical substances into a dosage form and its packaging into a finished pharmaceutical product, e.g. tablet.
Ongoing and systematic monitoring of the safety of a proprietary medicinal product with the objective to discover, assess and understand its adverse effects in order to take the necessary measures to minimize risks.
The formal “true statement” of a drug, approved by the FDA, which contains all the details that healthcare providers need to prescribe the drug properly. The prescribing information typically includes the chemical formulation of the drug, indication, results of clinical trials, side effects, warnings, contraindications, dosing, and directions for use. Also commonly called the product information, product labeling, and package insert (PI).
Market segment for drugs requiring a prescription, also termed the Rx market.
The legal requirement specifying that, depending on the potential risk involved, drugs may be dispensed to patients on prescription only.
An ad that names the drug and the condition it treats, and discusses the beneﬁ ts and risks. This kind of ad requires fair balance and brief summary.
"Product-claim" ads are those ads which generally include both the name of a product and its use, or make a claim or representation about a prescription drug. Claims of drug benefits, such as safety and effectiveness, must be balanced with relevant disclosures of risks and limitations of efficacy. This balanced presentation of drug therapy is commonly referred to as "fair balance." In addition, when used in print ads, sponsors must provide a brief summary of risk information included in the product's FDA-approved labeling or, for broadcast "product-claim" ads, provide convenient access to the approved labeling. In FDA regulations, the phrase "adequate provision" is used to identify the convenient access option.
Materials used to sell a drug that are delivered in ways other than through the general media. Examples include brochures, booklets, mailers, and videos. All promotional labeling must be accompanied by the drug's prescribing information.
Active pharmaceutical ingredient specific and/or active pharmaceutical ingredient combination specific reimbursement limit for drugs in the public health care system. If the price of a drug is above the reference price and it is not exchanged for a cheaper drug with the same active ingredient, then the patients must bear themselves as an additional contribution the difference to the reference price.
Relationship or DR marketing is designed to achieve two-way dialogue with the prospect. The one-on-one nature of direct-response marketing is ultimately designed to affect behavior.
"Relationship marketing is permission-based. Communications are anticipated and relevant instead of random. Every communication asks for dialogue with respect. When permission is obtained, it creates a positive brand experience at every touch point.
A reminder ad mentions the pharmaceutical brand name but not the indication or medical condition it treats.
Rituximab is a monoclonal antibody used in the treatment of various forms of cancer, such as non-Hodgkin lymphomas, as well as various auto-immune diseases, such as rheumatoid arthritis.
The sales aid -- also known as a detail aid or visual aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The sales aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.
A sales aid usually is composed of information about the product's efficacy, clinical data that support the manufacturer's claims, charts and graphs, guidance for dosing and administration of the drug, and summary information pertaining to the product's tolerability and safety. It may also include the official labeling. The sales ad is primarily a marketing tool that incorporates creative elements such as photos, slogans, and brand logos .
Sampling (ie, Drug Sampling) is the process by which pharmaceutical companies distribute free drugs (Drug Samples) to physicians. According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor.
In the pharmaceutical market: a company that markets a drug that is identical with respect to the qualitative and quantitative active ingredient composition to another drug introduced previously in the market.
Market segment for drugs that patients select, pay for and administer themselves.
Supplementary Protection Certificate is commercial property right in the EU that extends the market exclusivity of the initial supplier by up to five years after patent expiration. SPCs must be applied for in each individual country; the date of the first EU approval is relevant for the beginning of the SPC period. The SPC period can vary from country to country.
Procedure for the review of drugs in Germany that were already on the market in 1976 when the Pharmaceutical Act came into effect. Applications for subsequent approvals for these products were required to be submitted no later than April 30, 1990. Subsequent approval has still not been completed for some drugs; these so-called “Alt-Arzneimittel” are still in circulation on the basis of the interim regulations.
The European Union equivalent of the prescribing information in the United States. The SPC is the basis of information for health professionals on how to use a drug safely and effectively.
This legislation controls drug advertising in Germany.
"A 'thought leader' is defined as a physician with a large patient population who can write a lot of pharmaceutical drugs.
An FDA Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of a Warning Letter.
Agency within the US Department of Health and Human Services responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.
The visual aid -- also known as a detail aid or sales aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The visual aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.
An FDA Warning Letter is a correspondence that notifies a pharmaceutical or other FDA-regulated company about violations that FDA has documented during its inspections or investigations.
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