Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information October 2009
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.
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-2007-D-0302 .