Comments Regarding Citizen Petition from Greenberg Traurig

Docket Number:

FDA-2022-P-0896

Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.

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Issues:

OTC Medicines

Monograph Reform

User Fees

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