FDA Regulations (SBIR)

During this 40-minute On Demand workshop, David McClure, Senior Consultant with Foresight Science & Technology, Inc. describes the regulatory activities of the Food and Drug Administration (FDA).  Dr. McClure highlights the Agency’s regulation of drugs, medical devices, and biologics.

Dr. McClure also discusses 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.   Dr. McClure dives into technology commercialization – including the path to market – and touches on some of the related legal aspects.

During this On Demand workshop, you will also learn:

• what FDA regulates;
• how FDA regulates;
• drugs FDA regulates;
• medical devices regulated by FDA;
• biologics regulated by FDA; and
• examples of the the above.
  

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

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