Simplifying Global Compliance
Regenerative Medicine and Stem Cell Regulation – Webinar Recording/Transcript
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Regenerative Medicine and Stem Cell Regulation: What You Need to Know
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If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells.
You’ll gain an understanding of the FDA’s regulations and enforcement, and how stem cell stakeholders (pharma/biotech companies, healthcare providers) can best comply.
As a lawyer with a Ph.D. in molecular biology and an M.A. in biomedical ethics, Barbara A. Binzak Blumenfeld, Ph.D. is uniquely qualified to address how the law and stem cell science converge. A shareholder in the FDA & Biotechnology practice group at Buchanan Ingersoll & Rooney PC’s Washington DC office, Dr. Blumenfeld will explain the latest on FDA’s interpretation of its stem cell regulatory framework, including its recent enforcement of that interpretation.
Presentation Takeaways:
- The FDA regulatory framework in 21 C.F.R. Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps)
- How to distinguish between HCT/Ps that are:
- Exempt from FDA regulations
- Only subject to certain FDA regulations (361 HCT/Ps)
- Require full FDA pre-approval prior to marketing (351 HCT/Ps)
- FDA’s November 2017 regenerative medicine framework, including new and revised guidance documents that address:
- The same surgical procedure exception
- Minimal manipulation and homologous use
- The regenerative medicine advanced therapies (RMAT) designation
- Development of devices used with stem cell therapies
- Enforcement efforts that FDA has taken since November 2017, including the issuance of warning letters and industry letters and relevant court actions against California Stem Cell Treatment Center, Inc. (California) and U.S. Stem Cell Clinic LLC (Florida)
- FDA’s recent victory in the U.S. Stem Cell case in Florida, and what it means for companies and physicians moving forward
- FTC’s October 2018 settlement with Regenerative Medical Group and Telehealth Medical Group (California) for false and misleading consumer advertising
- The New York State Attorney General’s case against Park Avenue Stem Cell (New York)
- Various opportunities for the legal development and use of stem cells
FDA’s enforcement actions have been ramping up. You must begin preparing now… start with this presentation!
- Pharmaceutical/biotechnology companies
- C-suite Management
- R&D
- Regulatory Affairs
- Hospitals, medical clinics, physicians
- C-suite Management
- Patient Services
- Regenerative Medicine Center Directors
- Individual Physicians
Barbara A. Binzak Blumenfeld, Ph.D. is a shareholder in the FDA & Biotechnology practice group at Buchanan Ingersoll & Rooney PC’s Washington DC office. She holds a law degree and an M.A. in biomedical ethics from Case Western Reserve University and a Ph.D. in molecular biology from the Mayo Graduate School. Dr. Blumenfeld’s unique educational background allows her to understand stem cell science and to apply the law to that science. She has advised stem cell clients in various capacities, including pre-IND meetings and IND submissions, advertising and promotion matters, investment funding deals and international inspection issues. Dr. Blumenfeld has also spoken and written about regenerative medicine and stem cell issues for several years, including for the Food and Drug Law Institute and Phaciliate Leaders World/the World Stem Cell Summit.
