FDA to reopen comment period on the cosmetics and foods portions of its guidance on determining if human research studies require an investigational new drug application

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FDA to reopen comment period on the cosmetics and foods portions of its guidance on determining if human research studies require an investigational new drug application

Published: Thursday, January 16, 2014

Editor's Note: In response to requests that it provide an additional opportunity to submit comments on these portions of the guidance, FDA has reopened the comment period.  This guidance is of interest to companies that perform human research  on their present or proposed products.

Food and Drug Administration

FDA to reopen comment period on the cosmetics and foods portions of its guidance on determining if human research studies require an investigational new drug application   

FDA has decided to reopen, for 60 days, the comment period for specific portions of its final guidance for clinical investigators, sponsors, and institutional review boards (IRBs), entitled "Investigational New Drug Applications (INDs) -- Determining Whether Human Research Studies Can Be Conducted Without an IND," which was announced in the September 10, 2013 Federal Register.   FDA will reopen the comment period only for subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).  The Agency is taking this action in response to requests that it provide an additional opportunity to submit comments on these portions of the guidance.

FDA will publish a notice in the Federal Register to announce the reopening of the comment period and will issue a Constituent Update when the exact date of the reopening of the comment period is known.

Additional Information:

  • Investigational New Drug Applications (INDs) -Determining Whether Human Research Studies Can Be Conducted Without an IND
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