Jun 17, 2022· Comment from Association for Accessible Medicines (AAM)· FDA-2022-D-0108-0003
FDA, The Association for Accessible Medicines (AAM) appreciates the opportunity to submit comments on the draft guidance, "Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use" (Docket No. FDA-2022-D-0108). Please find attached AAM's comments on this draft guidance. Thanks, Scott Kuzner, Ph.D. Senior Director, Sciences and Regulatory Affairs Association for Accessible Medicines (AAM)