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Although at times it seems that the extraordinary events relating to the outbreak of COVID-19 have been ongoing for years, we can trace the initiation of the formal U.S. government response to the declaration of a national emergency on Friday, March 13. In response, government regulators, pharmaceutical companies, and healthcare providers have taken actions to adapt existing processes, relating to healthcare delivery to the public health concerns over the pandemic, in addition to developing new ones.
Howard L. Dorfman founder of H.L. Dorfman Pharmaceutical Consulting, LLC and an adjunct professor at Seton Hall Law School, will discuss the current state of regulatory and commercial processes being implemented in response to the COVID-19 crisis and how these practices may evolve in the future.
Among the topics he will cover:
- how the FDA has revised the drug approval process to expedite research and development
- the extent to which off-label considerations are being addressed
- how pharmaceutical companies can limit exposure for pre-approval of investigational products
- posting clinical trial results in a compliant manner
- availability of a preemption defense
- how commercialization has developed in a virtual environment