GUIDANCE DOCUMENT
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry February 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-5473
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional materials) , for prescription reference products licensed under 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a))
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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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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2019-D-5473.