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GUIDANCE DOCUMENT

Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use Draft Guidance for Industry April 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0108
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes how FDA (the Agency, or we) intends to evaluate a request for a waiver, with regard to a pH adjuster, under 21 CFR 314.99(b) (hereinafter waiver) 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 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) (waiver request).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0108.

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