Scientific innovation and business concerns can easily become entangled in the U.S. regulatory framework for the pre-approval promotion of drug and medical devices. Once drugs and devices have been approved, however, promotional-related compliance concerns do not become any less complex.
The second course in this three-part series, led by attorney Dominck DiSabatino and regulatory expert Jennifer Stohlmann, examines three important areas of drug and medical device law in the United States: pre-approval promotion, direct to consumer advertising, and off-label promotion.
Examine the legal restrictions on what can be said in the pre-approval stage
Discuss the FDA & SEC Partnership
They presenters seemed very dutiful.
Great course. Thank you!