Regenerative Medicine - Webinar Recording/Transcript

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Regenerative Medicine: Understanding FDA’s New Approach to the Regulation of Stem Cells and HCT/Ps

The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies.

But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way?

Join us for 90 minutes in the company of such a lawyer. Andrew Ittleman Esq. represents physicians, hospitals and manufacturers in this booming area. He has litigated extensively against the FDA regarding scope and reach of the Part 1271 regulations.

Mr. Ittleman’s focus will be FDA’s new regulatory approach: Best practices for you to follow for compliance with laws, regulations and policies. You’ll discover:

  • How the FDA is interpreting “homologous use,” “minimal manipulation” and “same surgical procedure”
  • Parameters of the FDA’s 36-month enforcement discretion
  • About the FDA’s NEW RMAT pathway
  • About regulation of devices commonly used in regenerative medicine
  • And much more!

The FDA’s RMAT regulations offer both promise and peril, and these rules still are so new you need help sorting them out. This is the moment to get the help you need — without paying exorbitant legal fees.

This session is aimed squarely at the regenerative medicine community, including job responsibilities such as:

  • Executive suite
  • Doctors
  • Other caregivers
  • Researchers
  • Regulatory affairs/compliance
  • Legal counsel
  • Business development
  • Marketing/sales

Andrew Ittleman Esq. is a partner with Fuerst Ittleman David & Joseph, Miami. His practice focuses on the regenerative medicine sector, including physicians, hospitals and medical device manufacturers. He has litigated extensively against the FDA regarding scope and reach of the Part 1271 regulations.