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  1. For Patients

Guide to Submitting Comments to the FDA

FDA-FR Notice Patient Network

As a Regulatory Agency, FDA publishes rules that establish or modify the way it regulates; 

  • foods

  • drugs

  • biologics

  • cosmetics

  • radiation-emitting electronic products

  • medical devices

  • tobacco products

FDA rules have great impact on the nation’s health, industries and economy. These rules are not created by chance or in a vacuum. They are formed with the public’s help.

By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule. The public can submit comments about the proposed regulation directly to the agency (through the mail or online at www.regulations.gov).

On regulations.gov you can find, read, and comment on FDA draft guidances and other FDA related documents. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance before the close date.

All written comments should be identified with the docket number found in brackets in the heading of this document.

To submit written comments:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852 


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