transcript   Transcript

New CURES Law and What It Means for Industry

Recorded on: Feb. 15, 2017
Running Time: 01:03:30

Full Transcript:

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Taken from the briefing New CURES Law and What It Means for Industry recorded February, 2017 in New York.

On December 13, 2016, President Obama signed the Cures legislation, changing the way rare diseases are reviewed by the FDA, reworking the federal mental health infrastructure, implementing the Biden "Cancer Moonshot," and adding a wide range of provisions affecting drug and device manufacturers, providers, hospitals, and federal research. But what was added, what was left out, and how did the legislation come together?

Lecture Topics  [01:03:30]

Listen to Gary A. Heimberg of Covington & Burling LLP and David J. Farber of King & Spalding LLP as they address:

  • The new FDA rare disease and expedited approval pathways
  • Increased NIH funding, and the Biden "Cancer Moonshot"
  • Changes in stem cell treatment
  • Changes to home infusion and the new infusion benefit
  • New manufacturer Expanded Access requirements
  • Modernization of mental health treatments
  • Creation of the new combination product center at FDA
  • Numerous other issues folded into the Cures law

Presentation Material

  • 21st Century Cures Act
    David J. Farber, Gary A. Heimberg
  • New Cures Law and What it Means for Industry
    David J. Farber, Gary A. Heimberg
David J Farber ~ King & Spalding LLP
Gary Heimberg ~ Covington & Burling LLP
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