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Jul 272 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...

Jun 22, 20231 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Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on...

Mar 15, 20221 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...

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US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...