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USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions. The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or
Sharan Murugan
3 days ago7 min read
USFDA Guidance: Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs
Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-maki
Sharan Murugan
Jul 154 min read
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
In July 2025, the U.S. Food and Drug Administration (FDA) published its updated guidance for industry titled “ Formal Meetings Between...
Sharan Murugan
Jul 19, 20253 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...
Sharan Murugan
Sep 21, 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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
Sharan Murugan
Aug 10, 20232 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...
Sharan Murugan
Mar 28, 20231 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US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...
Sharan Murugan
Feb 6, 20221 min read