Clinical Development and Labeling of Anti-Infective Drug Products February 2001
- Docket Number:
- None found
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
Changing or unclear interpretations of clinical trail data needed to demonstrate the effectiveness and safety of anitmicrobial drug products have at times lead to confusion and frustration on the part of both applicants and Division of Anti-Infective Drug Products reviewers.
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: None found.