Regulatory Terms Starting With A

9 terms in the A index.

• Abbreviated 510(k) (Abbreviated 510(k))

  Abbreviated 510(k) is a premarket notification format in which conformance to an FDA-recognized consensus standard, special control, or guidance document substitutes for the device-by-device test summaries a Traditional 510(k) requires.

• Abbreviated New Drug Application (ANDA)

  Abbreviated New Drug Application (ANDA) is the FDA marketing application for a generic drug, which wins approval by demonstrating bioequivalence to a reference listed drug rather than repeating the clinical safety and efficacy trials behind an NDA.

• Accelerated Approval (AA)

  Accelerated Approval is an FDA pathway that grants marketing approval for serious or life-threatening illnesses on a surrogate endpoint reasonably likely to predict clinical benefit, conditioned on postmarketing studies that verify and describe that benefit.

• Active Pharmaceutical Ingredient (API)

  Active Pharmaceutical Ingredient (API), also called the drug substance, is the component of a drug product intended to furnish pharmacological activity or other direct effect on the body. Every other component of the dosage form is an inactive ingredient.

• Adaptive Trial Design (Adaptive Design)

  Adaptive trial design is a clinical trial design whose prespecified rules let interim data change sample size, dose, arms, or enrollment mid-study, unlike a fixed design, which locks every parameter before the first subject is dosed.

• Adverse Event (AE)

  Adverse Event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product, recorded whether or not it is considered drug related; causality is assessed separately, not presumed.

• Annex 1 (EU GMP Annex 1)

  Annex 1 is the European Union GMP guideline governing the manufacture of sterile medicinal products, distinguished from other GMP annexes by mandating a facility-wide Contamination Control Strategy and graded cleanroom control, in force since 25 August 2023.

• Annual Report (AR)

  Annual Reports are the yearly postmarketing filing required for every approved NDA, ANDA, and BLA, covering distribution, labeling, and minor manufacturing changes that do not rise to the level requiring a supplement.

• Audit Trail

  Audit trail is the secure, computer-generated, time-stamped metadata record of who created, modified, or deleted a regulated record and when, captured independently of the record so that previously recorded values are never obscured.