GUIDANCE DOCUMENT
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers October 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2008-D-0053
- Docket Number:
- FDA-2008-D-0053
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Veterinary MedicineOffice of the Commissioner
This revised draft guidance, when finalized, will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products. Specifically, this guidance relates to firms sharing the following types of communications with HCPs:
• Published scientific or medical journal articles (reprints)
• Published clinical reference resources, as follows:
- - Clinical practice guidelines (CPGs)
- - Scientific or medical reference texts (reference texts)
- - Materials from independent clinical practice resources
• Firm-generated presentations of scientific information from an accompanying published reprint