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Sep 21, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...

Aug 10, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...

Mar 28, 20231 min read

USFDA Update: In-Person, Face-to-Face ANDA Program Meetings

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...

Feb 6, 20221 min read

USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...