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GUIDANCE DOCUMENT

Benefit-Risk Considerations for Product Quality Assessments May 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0168
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), original biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment.

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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-0168.

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