21 CFR Part 11

Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA. See Code of Federal Regulations (CFR).

505 (b) (2) submission

A new drug application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

Abbreviated Antibiotic Drug Application (AADA)

A marketing application usually reserved for antibiotics that duplicate products that were previously approved under a full marketing application. Similar to an ANDA.

Abbreviated New Drug Application (ANDA)

Application made to the FDA for a generic version of a branded drug. The duplicate drug must be bioequivalent to the branded version of the drug. The first company to receive FDA approval of an ANDA receives 180 days of market exclusivity for the generic drug. Compare with NDA.

Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T)

The objective of ADME/T testing is to measure what happens to a compound in the human physiology. ADME/T tests are done during the preclinical stage of the drug discovery process and are a necessary part of any clinical trial, prior to filing an IND.

Action Letter

An official communication from the FDA to the sponsor of an NDA, regarding a decision before the agency.

Active Pharmaceutical Ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture of a drug product and that becomes an active ingredient of the drug. APIs are intended to cause pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.

Adverse Drug Reaction (ADR)

An adverse drug reaction is an undesirable effect associated with the use of a drug. It may occur as a standard part of the drug’s action, or it may be unpredictable.

Agonist

An agonist is a substance or a drug that can interact with a receptor and initiate a physiological or a pharmacological response characteristic of that receptor.

Ampoule (Ampule)

A small glass vial sealed after filling. Ampoules were one of the earliest devices developed for safe storage of a sterile injectable.

Antagonist

An antagonist is a drug or a compound that opposes the physiological effects of another. At the receptor level, it is a chemical entity that opposes the receptor-associated responses normally induced by another bioactive agent.

Antibiotic

An organic substance of microbial origin that is either toxic to, or inhibits the growth of other organisms. Examples include penicillin, tetracycline, and erythromycin and semi-synthetic derivatives. Totally synthetic antibiotics (or “antibacterials”) also exist, such as the quinolones.

Antibody

A protein molecule in the blood serum (and other bodily fluids) produced by the immune system in response to exposure to a foreign substance. Antibodies are the body’s protective mechanism against infection and disease. An antibody is characterized by a structure complementary to the foreign substance (the antigen that provokes its formation), making it capable of binding specifically to the foreign substance to neutralize it.

Antifungal

A medication used to treat fungal infections such as athlete’s foot, ringworm, candidiasis (thrush), serious systemic infections such as cryptococcal meningitis, and others.

Antigen

Any foreign or “non-self” substance that, when introduced into the body, causes the immune system to create an antibody.