FDA Regulations (SBIR)

This class was originally developed to support SBIR Phase 0 applicants but it is not specific to those clients and is available for everyone.

In this 40-minute on-demand webinar, Foresight Science & Technology Senior Consultant, Dr. David McClure describes the regulatory activities of the Food and Drug Administration (FDA), highlighting in particular the Agency’s regulation of drugs, medical devices, and biologics. A particular emphasis is placed on the intended use of regulated products and the requirements of various applications such as IND, 510(k), PMA, and BLA. Compliance (registration and listing) and enforcement (adulteration; misbranding, warning letters) are also briefly covered. While legal aspects are mentioned, the primary perspective is that of technology commercialization, including path to market.

Topics include:

• What FDA Regulates
• How FDA Regulates
• Drugs
• Medical Devices
• Biologics
• Examples 

Presented by: Dr. David McClure – Senior Consultant, Foresight Science & Technology

This class is generously sponsored by Alaska EPSCoR and the SBDC Trend Program and provided to you free of charge.