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GUIDANCE DOCUMENT

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs October 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-1864
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

This guidance is intended to assist applicants who are submitting abbreviated new drug 17 applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called 19 topical products.2 Because of the complex route of delivery associated with these products, 20 which are typically locally acting, and the potential complexity of certain formulations, topical 21 products (other than topical solutions) are classified as complex products.3

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1864.

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