An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Abbreviated New Drug Application (ANDA)

Question-Based Review for Sterility Assurance Evaluation (Product Quality Microbiology Review) of ANDAs

Sterility Assurance - Quality Overall Summary (SA-QOS) Outline for Terminally Sterilized Products (PDF - 21KB)
QbR for Sterility Assurance of Terminally Sterilized Products: Frequently Asked Questions (PDF - 115KB)

Top