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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

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2008-D-0053
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office 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This revised draft guidance, when finalized, will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of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

Submit Comments

Submit Comments Online

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-2008-D-0053.

 
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