FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

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FDA’s Work Plan ... the 21st Century Cures Act ... and You: Disruptive? Absolutely. But ... How Much?

The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it.

Every FDA-regulated health sciences company will be affected. That means you.

Just in time, FDAnews has stepped into the knowledge vacuum with legal and regulatory counsel from the attorney the Supreme Court hailed as “the expert” on medical-device law.

In 90 fast-paced minutes, Prof. Jim O’Reilly Esq. of the University of Cincinnati College of Law will reveal current FDA thinking and touch on the gut issues affecting makers of drugs, devices and biologics ... operators of clinical trials ... and every other health science company under FDA jurisdiction. Expect this presentation to help you:

  • Understand how  FDA Science Board's new standards can lead to much faster product development approvals 
  • Develop best-in-class qualified data summaries can get your product to market faster 
  • Gain  faster agency approval of biomarker-based drug applications and breakthrough device applications
  • Better navigate device and drug channels toward approval of new combination products
  • Understand how the new oncology coordination process will impact product development
  • Understand how the FDA will allocate its $500 million in funding to affect your products directly
  • Understand the new role of the Office of Translational Sciences, which governs the bench to clinical process
  • And much more!

Why spend literally thousands of dollars per hour bringing Mr. O’Reilly to your organization for a sit-down when it’s so easy — and inexpensive too get up to speed on this critically important change in FDA regulation? Order now.

  • Planning/corporate strategy
  • Regulatory affairs/compliance
  • Quality by Design executives
  • Manufacturing executives
  • Marketing/advertising
  • Legal counsel

Jim O’Reilly Esq. teaches food and drug law at the University of Cincinnati College of Law. The author of 53 texts and 215 articles, he was quoted in a 2000 Supreme Court ruling as “the expert” on medical-device law. He chairs the FDA Committee of the American Bar Association; serves on the Editorial Advisory Board of FDLI’s Food and Drug Law Journal; and is the longtime program chair of FDLI conferences.