Summary for New Drug and Antibiotic Applications–Format and Content of the Summary for New Drug and Antibiotic Applications

Issue Date: February 1, 1987
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final

Summary for New Drug and Antibiotic Applications–Format and Content of the Summary for New Drug and Antibiotic Applications

This guideline is intended to assist drug firms in preparing the summary to a new drug application required under 21 CFR 314.50(c).

Download the Guidance Document