Insight Center: Events

Health Sciences Speaker Series, 'The Off-Label Debate and FDA's Shifting Outlook'

Speakers: Michael A. Schwartz and Erin Colleran

8:00-9:30 AM (EDT)
Health Sciences Speaker Series, 'The Off-Label Debate and FDA's Shifting Outlook'

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 us 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 Pennsylvania. Attorneys licensed in New Jersey may claim credit for this program under New Jersey's reciprocity policy.

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 across the health sciences spectrum.


Philadelphia Country Club
1601 Springmill Road
Gladwyne, PA 19035

Event Documents

The Off-Label Debate and FDA's Shifting Outlook Presentation Slides (.pdf)


There is no cost to attend this event.

Contact Kim MacAlister at macalisk@pepperlaw.com or 215.981.4249 with any questions.

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