Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products

Clinical/Medical; Investigational New Drug Applications; Pharmacology/Toxicology

http://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-...

Source: FDA Center for Drug Evaluation and Research - What's New - June 11, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

More News: Biotechnology | Drugs & Pharmacology | Investigational New Drugs | New Drug Applications | Study | Toxicology