FDA publishes draft guidance for industry: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

April 14, 2022

On April 13, 2022, FDA published a new draft guidance for industry entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.”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 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, under 21 CFR 314.99(b) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv) that a drug product 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 This draft guidance also provides recommendations regarding the timing and process for requesting such a waiver of the requirement in §314.94(a)(9)(iii) and (iv).

This draft guidance provides assistance to ANDA applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval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). This guidance identifies the type of information 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 This draft guidance may reduce the burden on generic drug applicants by enabling flexibility in the regulatory requirements for how a particular applicant meets the statutory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.

This draft guidance does not introduce any new policies; it clarifies FDA’s recommendations for applicants requesting 314.99b waivers and FDA’s waiver request evaluation process. The recommendations in this guidance are limited to inactive ingredients in ANDAs that adjust the pH of a drug product intended for parenteral, ophthalmic, or otic use, and do not apply to other inactive ingredients.

FDA is issuing this guidance as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process. An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines that can, in turn, help consumers lower their health care costs.

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