- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under 21 CFR 201.56(d)
and 201.57. FDA is issuing this guidance to provide recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs. This guidance also provides recommendations on developing Highlights of Prescribing Information (Highlights), formatting labeling, and procedural information.
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:
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-2005-D-0153.