Guidance for industry, q & a content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

Other Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format: Electronic
Language: English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000]
Physical Description: 1 online resource (4 unnumbered pages)
Subjects:
Online Access: https://purl.fdlp.gov/GPO/LPS119805
https://purl.fdlp.gov/GPO/LPS119805

CMU Gov Pub Electronic

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LocationCall Number: Status
CMU Gov Pub Electronic HE 20.4702:IN 8/2 Available