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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
2 days ago4 min read
USFDA Announcement: Facility Fee Rates for OTC Monograph Drug User Fee Program (OMUFA) for FY 2025
The U.S. Food and Drug Administration (FDA) has announced the release of " Over-the-Counter Monograph Drug User Fee Program-Facility Fee...
Sharan Murugan
Mar 21, 20252 min read
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...
Sharan Murugan
Jul 27, 20242 min read
USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on...
Sharan Murugan
Jun 22, 20231 min read
USFDA Guidance: Format and Content for OTC Monograph Order Requests
Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...
Sharan Murugan
Apr 12, 20231 min read
FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022
Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...
Sharan Murugan
Mar 15, 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US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...
Sharan Murugan
Feb 6, 20221 min read