Expert Webinar: Sweeping De-Regulation through the 21st Century Cures Act?
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Although touted to accelerate the discovery and development of new medical products, the de-regulation of FDA approval authority through the 21st Century Cures Act is reminiscent of pre-1962 times. Instead of accelerating innovation, the Act might just allow under-developed products to reach the market that have been prevented for decades. The Act has been passed, the rules have been changed, and your products have already been impacted – including new competitors you might not have had before. Learn from subject expert, Jim O’Reilly, the extent of impact we will witness for years to come.
The 21st Century Cures Act became law in December 2016. This Expert Insight is a comprehensive review of how the 21st Century Cures Act impacts medical device and drug manufacturers.
- The Act’s touted purpose was to accelerate the discovery, development and delivery of new medical products.
- This law revises many of the FDA’s device, drug, biologic and combination products approval and review norms that has resulted in expansive de-regulation.
- Understand how the rollout of the new law in the next 4 years will be impacted by the Trump Administration’s changes to the leadership and direction of FDA, CMS and other agencies.
Brand new law deserves veteran expert analysis. In this two hour Expert Webinar, longtime FDA law professor Jim O’Reilly guides you through what the highly targeted lobbying by industry has produced in the law. He offers a neutral scholar’s view of the significant changes that must now occur how FDA firms have been regulated in the research and pre-approval stages of drug and device development.
Who should listen: Your company’s Regulatory, R&D, Clinical Trials and Compliance teams
Investment: $250 includes the recorded program and download of handouts for your organization to study and review as you implement the complex new statute. You’ll receive a highlighted download of the key provisions and suggestions for further study within your organization.
Professor, University of Cincinnati
Prof. Jim O’Reilly authored the standard reference encyclopedia on FDA for Thomson-Reuters-Westlaw, “Food & Drug Administration” (4th ed, 2016) which the U.S. Supreme Court quoted as “The experts have written…” in a major FDA decision in 2000. He taught FDA law for 28 years and chairs the American Bar Assn. FDA Committee. Before coming to academia he was Procter & Gamble’s FDA expert and is the last active survivor of the group that negotiated the historic 1975-76 Medical Device Amendments.