Business · 29/09/2008Updated: 10/17/2026 · 1 min read
FDA Amends Regulations for Authorized Generic Drugs
Summary
The Food and Drug Administration (FDA) is requiring the holder of a new drug application (NDA) to submit annual reports on authorized generic drugs as part of the implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →