July 19 - July 23, 2021
The Regulatory Education for Industry (REdI) Program is an FDA-led forum that brings together the regulatory educators from FDA's medical product centers: Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER). Program is free
Featuring three medical product center tracks:
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements.
Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
This plenary session will reflect on FDA’s use of Emergency Use Authorizations (EUAs) and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
An emergency use authorization, or EUA, is a regulatory pathway that allows FDA to help strengthen the nation’s public health protections by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under this pathway, FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.
Patrizia Cavazzoni M.D.
Center for Drug Evaluation and Research (CDER)
Jeff Shuren M.D., J.D.
Center for Devices and Radiological Health (CDRH)
Peter Marks M.D., PhD.
Center for Biologics Evaluation and Research (CBER)
The drugs trackExternal Link Disclaimer will focus on the operations of Center for Drug Evaluation and Research (CDER) offices directly involved in the drug assessment process and their interaction with each other.
The devices trackExternal Link Disclaimer will focus on evidence quality and data expectations that impact regulatory decisions involving medical devices regulated by the Center for Devices and Radiological Health (CDRH).
The biologics trackExternal Link Disclaimer will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, plasma-derived therapeutics, and devices regulated by Center for Biologics Evaluation and Research (CBER). Different aspects of product development will be discussed (product quality, pharmacology toxicology, and clinical).
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been: