Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 14, 2022
May 19, 2022
72d47f74-c8a1-4b7b-8d10-222b23fcd90c
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