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GUIDANCE DOCUMENT

Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events June 2009

Final
Docket Number:
FDA-2009-D-0217
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist manufacturers of prescription drugs approved under section 505 of the Federal Food, Drug, and Cosmetics Act (the Act) (21 U.S.C. 355) that are required to have an FDA-approved Medication Guide. On July 1, 2009, FDA expects affected entities to be in compliance with 21 CFR 208.20(b)(7)(iii), which requires that Medication Guides contain a verbatim statement that includes: (1) FDA’s toll-free MedWatch phone number and (2) a statement that the number is to be used for reporting purposes only, not to receive medical advice (the side effects statement). Manufacturers must also notify the Agency that the side effects statement has been added to their Medication Guides.


Submit Comments

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-2009-D-0217 .