Please join us for the first webinar in a two-part series on the impact of FDA's Intended Use Final Rule. This webinar will quickly get you up to speed on the implications of the new regulations—effective September 1, 2021— which expand manufacturers’ potential liability for misbranding and new drug violations (and analogous violations for devices) under the FDCA, and raise questions as to the scope and durability of “safe harbor” policies established by FDA to allow certain types of manufacturer speech about off-label uses.
We will also discuss the implications of the final rule for scientific exchange, responses to unsolicited requests, and reprints/textbooks/clinical practice guidelines, as well as the potential implications for government enforcement.
This webinar will provide critical updates and insights for:
- Lawyers and regulatory affairs professionals involved in supporting medical affairs and medical communications
- Lawyers and compliance professionals involved in assessing and addressing issues that give rise to government enforcement risk
Coleen Klasmeier, Partner & Global Leader, Food, Drug and Medical Device Regulatory Practice
Jaime Jones, Partner & Global Co-Leader, Healthcare Practice
For more information, contact GlobalLifeSci@sidley.com