FDA relations during drug development
Year: 2000
Type: article
Abstract: Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.
Author: Jules T. Mitchel
Language: English
Subfield: Issues, ethics and legal aspects
Field: Nursing
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W89094205