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.
- 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