TERMINOLOGIES IN DRUG INDUSTRY Abbreviated New Drug Application (ANDA) Under an ANDA, proof of bioequivalence is enough to satisfy FDA safety and efficacy requirements for a generic drug. The ANDA was established by the Waxman-Hatch Act. In addition, the generic manufacturer needs to certify that the original drug is either (a) not patented, (b) has an expired patent, (c) has a patent expiry date before which the generic will not be sold, or (d) has an invalid patent or a patent that the generic does not infringe. Accelerated Development After the IND has been filed, a drug that can be used by patients who are suffering from life-threatening conditions, for which no other drug treatment exists, can qualify for accelerated development. Biological Drugs Biological drugs are biologics such as insulin, penicillin, blood and blood products, vaccines, derivatives of natural substances, and extracts of living cells are grown or cultured in separate batches. Ethical Drugs Also known as legal drugs. FDA Modernization Act of 1997 It reduced FDA bureaucracy and speeding drugs and devices to patients. Food, Drug, and Cosmetic Act of 1938 It required pharmaceutical manufacturers to submit a New Drug Application to prove the drugs safety. The act also provided the basis for the distinction between prescription and nonprescription drugs. Generic Drugs After the patent for a drug expires, other manufacturers may produce an equivalent drug and sell it under the drug?s chemical or ?generic? name. Good Manufacturing, Laboratory, and Clinical Practices (GMP, GLP, and GCP) The various Good Practices are lengthy FDA rules and regulations governing manufacturing, laboratory, and clinical facilities. Institutional Review Board (IRB) IRB reviews, approves, and monitors clinical studies involving human subjects in order to evaluating the ethical acceptability and the scientific validity of the studies. Investigational New Drug Application (IND) Before testing a new drug on human subjects, the company must file an IND. Prior to filing an IND, the sponsor develops information on the chemistry of the drug so that it can be produced in batches of known strength and purity. In addition, the sponsor must conduct a number of animal studies to produce information on the pharmacology and toxicology of the drug. For details, please, check our Section of Drug Development. New Chemical Entities A chemical entity that has never been used by humans and has been tested only on animals. New Drug Application (NDA) NDA is submitted to the FDA for evaluating the new drug product?s efficacy as well as its safety. Orphan Drug Orphan drug refers to the drug that nobody wants to develop because its market is small. Over-the-Counter Drug (OTC drug) A drug that is available to the consumer without a prescription. Placebo A placebo is a pharmacologically inert capsule, injection or procedure. It has the same composition as the test product does, except the active ingredient (i.e. the drug). Preclinical Research It is the first stage in drug development involving synthesis and purification testing in the lab and animal testing. Prescription Drug A drug that is available to the consumer only with a doctor?s prescription Supplemental New Drug Application (SNDA) The off-label uses of a drug may become additional on-label uses if the company submits a Supplemental New Drug Application and the FDA approves the application. Waxman-Hatch Act It reduced the barriers to entry for generic drug producers by allowing them to assert safety and efficacy based on a proof that the original drug and generic drug are bioequivalent. The submission procedure for a generic drug is called an Abbreviated New Drug Application (ANDA). HOME |
DRUG TERMINOLOGIES updated on April 26, 2005 email zhion@zhion.com |