miércoles, 18 de enero de 2017

Draft Guidance: Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery

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Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery

On January 11, 2017, FDA posted a draft guidance for industry regarding cardiovascular-related imagery for aspirin-containing over-the-counter drug products. This guidance document is being distributed for comment purposes only.  Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Click here for the draft guidance document.
Submit electronic comments to http://www.regulations.gov or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Emily Baker at 301-796-7524.

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

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