FDA Regulation of Regenerative Medicine - Webinar CD/Transcript

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FDA Regulation of Regenerative Medicine: Risks and Opportunities in a Shifting Regulatory Environment

The regenerative medicine industry is rapidly growing and, with major court decisions, new and significant FDA guidance, and government enforcement actions, the regulatory landscape is more complex than ever.

This webinar CD and transcript identifies key trends and policies affecting the regenerative medicine industry in 2016 including:

  • How FDA is expected to regulate regenerative medicine in 2016 and beyond
  • How FDA will deal with ethical issues associated with stem cell research
  • How FDA’s oversight of regenerative medicine compares to global regulation
  • How likely it is that Congress will pass legislation on regenerative medicine
  • Why regenerative medicine contains so much political baggage
  • How associations are influencing the regenerative medicine debate

Order today to gain a comprehensive understanding of the FDA’s current regulatory policies and enforcement trends affecting the regenerative medicine industry.

  • Regulatory Affairs
  • Quality Control
  • Legal
  • Business Affairs

Meet Your Presenters

Andrew Ittleman, Esq., Founder and Partner, Fuerst Ittleman David & Joseph, PL
Andrew Ittleman exclusively represents clients in highly regulated industries, such as regenerative medicine and other FDA-regulated issues. Ittleman has been invited to speak at numerous conferences and panels on FDA enforcement issues, FDA regulation of stem cells and FDA regulation of off-label use. He also litigates extensively against the United States government in civil and criminal matters.

Kelly Lightfoot, Esq., Senior Associate, Fuerst Ittleman David & Joseph, PL
Kelly Lightfoot represents a variety of participants in the regenerative medicine industry, both public and private, including biologics manufacturers, clinical trial sponsors, medical device manufacturers, cryogenic banking facilities, medical tourism businesses, and physicians engaged in the development of autologous stem cell therapies.