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FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.


The guidance is intended to assist applicants in preparing an abbreviated new drug application (ANDA) by describing how FDA intends to evaluate a request for a waiver, with regard to a pH adjuster, for drug products intended for parenteral, ophthalmic, or otic use generally “must contain the same inactive ingredients and in the same concentration as the reference listed drug identified by the applicant.”

This draft guidance also provides recommendations regarding the timing and process for requesting such a waiver and provides assistance to ANDA applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the RLD with respect to a pH adjuster(s).


It identifies the type of information the FDA may generally consider in evaluating a waiver request for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use and provide recommendations to ANDA applicants regarding the submission and content of such a waiver request.


This may reduce the burden on generic drug applicants by enabling flexibility in the regulatory requirements for how a particular applicant meets the statutory standards for approval. FDA will consider these waiver requests on a case-by-case basis.


Click this LINK to know more details FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products.

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