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USFDA Guidance: Waiver Requests for pH Adjusters in Generic Parenteral, Ophthalmic, or Otic Drugs
The U.S. Food and Drug Administration (FDA) has released a final Guidance for Industry yesterday (17 November, 2025) titled “ Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use ” that is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different
Sharan Murugan
11 hours ago3 min read
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read