The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
|Articles|July 28, 2020
Regulatory Affairs’ Role in Product Development
Author(s)PDA
This excerpted chapter of a longer book reviews the history of the Food, Drug, and Cosmetics act, including milestones, subsequent laws, and predictions for future laws and regulations; explores the role of Regulatory Affairs in product development; and addresses the importance of a quality management system and organization in bringing products to market.
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