RAPS Off-Label Use of FDA-Approved Drugs and Devices

May 17, 2018 Morristown, NJ

Porzio Life Sciences Vice President Jennifer A. Romanski presented during the Regulatory Affairs Professionals Society (RAPS) New York/New Jersey Chapter's "Off-Label Use of FDA-Approved Drugs and Devices" program, held at Porzio Life Sciences' Morristown office on May 17, 2018. 

Topics included: 

  • Recent changes in the off-label landscape
  • 21st Century cures act - changes to FDAMA 114
  • Delay of intended use rule
  • Impact on promotional review practices and scientific communications
  • Tips to prevent violations


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