Search


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
Nov 17, 20253 min read
