This rapidly growing area raises a number of unique and complex legal questions specific to regenerative medicines. Our presentation will provide an overview of the regulatory framework for regenerative medicine products, key definitions and concepts, expedited programs for RMATs, FDA enforcement, and factors HCT/P manufacturers should consider when deciding whether to submit investigational new drug applications or marketing applications.
This roundtable will cover:
– The basics of regenerative medicine regulation
– The end of FDA’s enforcement discretion period (2017-2021) and what that means for manufacturers
– Regulation of “section 361” products and “section 351” products
– Regenerative Medicine Advanced Therapy (“RMAT”) designation and other expedited programs
– Regulatory exclusivities, including reference product and orphan drug exclusivity
If you have questions concerning this roundtable webinar, email Chayako Williams at firstname.lastname@example.org.
King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, email@example.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.
General information on our practice is available in our electronic publications Serving the Life Sciences Industry and Serving the Healthcare Industry. If you would like to be included on our regular pharmaceutical manufacturers, medical device manufacturers or healthcare provider mailing lists to receive notices of other events and written updates, you can be added by submitting your full contact information to firstname.lastname@example.org and specifying the list you wish to join.