Withdrawn CDER Product Specific Guidances

Docket Number:

FDA-2007-D-0369

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Updated August 28, 2026.

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-2007-D-0369.

BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET

BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET