Join the RAPS NJNY Chapter for a timely and insightful session which will delve into the evolving landscape of FDA advertising and promotional enforcement, as well as recent FDA guidance. Participants will gain a comprehensive understanding of:
- Key trends in FDA’s Office of Prescription Drug Promotion (OPDP) enforcement activities, including analysis of recent warning/untitled letters.
- Challenges and practical take-aways from FDA’s Final Guidance, “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (the “SIUU Guidance”)
- Strategies for proactive risk mitigation, including internal training and cross-functional collaboration.
Refreshments (light dinner) will be provided for all attendees; onsite registration will not be available. This event is graciously hosted by Porzio, Bromberg & Newman, P.C.
Agenda
5:00 – 6:00 Networking and Refreshments
6:00 – 7:00 Presentation
7:00 – 7:30 Q&A
Location
This event will take place at the law offices of Porzio, Bromberg & Newman, P.C., 5 Sylvan Way, Parsippany, NJ. There is free parking. The site is conveniently located 5 minutes from Morris Plains Train Station, which provides direct service to New York Penn Station, Midtown Manhattan and Hoboken Terminal.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Jennifer Romanski
