Risk Evaluation and Mitigation Strategies (REMS): Update

Taft Pharmaceutical Litigation & Life Sciences chair Steve Auten will be one of the featured speakers at the 7th Annual Pharma IPR conference in Mumbai, India. Auten will present the session “Risk Evaluation and Mitigation Strategies (REMS): Update,” which will cover entering the U.S. markets and the implications of REMS; restricted distribution programs by branded drugs: threat to generics; and analyzing recent case laws. 

Auten is a widely recognized and seasoned attorney in Hatch-Waxman and biosimilar matters, including related patent litigation, and is followed by key industry leaders (brand and generic alike), law firms, analysts, educators and others on his LinkedIn blog “Hatch Waxman ANDA Litigation Forum,” which has more than 8,000 members worldwide. He currently represents clients primarily in the areas of Paragraph IV design strategies, Hatch-Waxman litigation and biosimilar market opportunities.