transcript   Transcript

FDA Regulation: Hot Topics

Recorded on: Oct. 12, 2017
Running Time: 01:15:44

Full Transcript:

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Taken from the Web Program Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries recorded October 2017 in New York.

FDA Regulation: Hot Topics [01:15:44]
  • UFA Reauthorization
  • FDA Enforcement: Advertising and Promotion, GMP/QSR, Adverse Event Reporting
  • Impact of the New Administration
  • A look at the legislative landscape

Nathan Brown, Scott D. Danzis

The purchase price of this segment includes the following article from the Course Handbook available online:

  • FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products (January 27, 2017)
    Nathan A. Brown
  • Senate Passes Long-Awaited FDA User Fee Package (August 4, 2017)
    Nathan A. Brown
  • The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions (January 3, 2017)
    Nathan A. Brown
  • Digital Health Innovation Action Plan
    Scott D. Danzis
  • FDA Initiates Software Precertification Pilot Program (August 3, 2017)
    Scott D. Danzis
  • FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan (August 3, 2017)
    Scott D. Danzis
  • H.R. 2430—115th Congress: FDA Reauthorization Act of 2017 (August 14, 2017)

Presentation Material

  • FDA Regulation: Hot Topics
Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Scott D. Danzis ~ Covington & Burling LLP
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