GDF2026 - Office of Pharmaceutical Quality (OPQ) Keynote

Food and Drug Administration (public forum) · July 30, 2026

0:00/12m

12:30

0:00

3:00

6:00

9:00

12:00

Opening and welcome

Presentation

0:00 → 0:22(21s)

An FDA presenter opened the generic drug forum, welcomed attendees and noted the presentation uses a standard OPQ slide deck. He framed the talk as an update on FDA initiatives affecting generic drug quality and availability.

Keywords:

Speakers:

An FDA presenter reviewed Office of Pharmaceutical Quality and Office of Generic Drugs initiatives, outlining the new PreCheck program, nitrosamine mitigation efforts, the Quality Management Maturity assessments, use of AI and CASA in reviews, and CDER research supporting generic drug access and cost savings.

AI-Generated Content

The text on this page is AI generated. Summaries, highlights, analysis, and video transcripts are all produced from the original source material.

AI can make mistakes, so if you spot one, and we will fix it for everyone.

Note: the source content is unaltered by us. Any content source we link to, be it a video, an audio recording, or a document, is presented exactly as its publisher released it. That publisher is usually a government body, sometimes an individual official or another organisation.

No transcript available.