The FDA is seeking volunteers from pharmaceutical companies to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products. The agency seeks more information on quality-by-design, risk-based approaches for manufacturing biotechnology products. The pilot will focus on products reviewed by the FDA's Office of Biotechnology Products (OBP), in the drug center's Office of Pharmaceutical Science and will assist the FDA in developing guidance for industry on quality-by-design and risk management in pharmaceutical manufacturing.
SOURCE: FDA Notice
For more information on this and related topics, consult the CCH Food, Drug and Cosmetic Law Reporter.
Visit our News Library to read more news stories.
Food, Drug and Cosmetics Law Reporter
Everything you need to know about Food and Drug Regulations.Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More »
|