Recent FDA action adds an important new element to the robust legal and policy debates on how drug and device manufacturers communicate with providers and payors. In two recent draft guidances and a First Amendment memorandum, FDA acknowledged a public health need for certain information outside the four corners of the approved product labeling, signaling a new flexibility. But a grey area between "on-label" and "off-label" communications still exists and requires careful navigation.
Please join Pepper attorneys Michael A. Schwartz and Erin Colleran for a seminar that will provide an overview of the current enforcement environment and the recent FDA issuances as well as discuss their practical implications for drug and device companies.
This seminar is approved for one substantive CLE credit in New York.
This event is sponsored by Pepper Hamilton's Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum.
Pepper Hamilton LLP
The New York Times Building
620 Eighth Avenue - 37th Floor
New York, NY 10018-1405
There is no cost to attend.
Contact Kim MacAlister at firstname.lastname@example.org or 215.981.4249 with any questions.