Regulatory Terms Starting With A

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

A 510(k) pathway that relies on FDA guidance documents, recognized consensus standards, or special controls to establish substantial equivalence.

Abbreviated New Drug Application (ANDA)

An application for FDA approval of a generic drug product that references an already-approved drug.

Accelerated Approval (AA)

An FDA pathway allowing earlier approval based on surrogate or intermediate endpoints for serious conditions.

Active Pharmaceutical Ingredient (API)

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

Adaptive Trial Design (Adaptive Design)

A clinical trial design that allows pre-planned modifications to aspects of the trial based on accumulating data, while maintaining trial integrity and validity.

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

Annual Report (AR)

A yearly report submitted to FDA summarizing changes and updates to an approved drug application.