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Clinical Evaluation of Anti-Infective Drugs (Systemic) September 1977

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

The FDA with assistance of its scientific Advisory Committees and other outside consultants, the American Academy of Pediatrics' Committee on Drugs, and consultants to the Pharmaceutical Manufacturer Association had developed guidelines for the clinical evaluation of new drugs.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.