- Do these documents illustrate a change of course for FDA, indicate a path for the future, or leave unanswered questions?
- What are the First Amendment implications?
This webinar will discuss these questions, as well as insights on how these two draft guidance documents might be implemented and the potential effect for drug and medical device companies. The draft guidance documents are open for comment until April 19, 2017.
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Speakers
Kristin Davis | Read Bio
Senior Policy Analyst, Office of the Commissioner, FDA
Paul Gadiok | Read Bio
Senior Attorney, Arent Fox LLP
PAUL GADIOCK is a senior attorney in the Food, Drug, Medical Device & Agriculture Practice at Arent Fox LLP. He provides premarket and postmarket regulatory solutions on a variety of subject matters for medical device clients. As a former policy director at FDA, Paul brings first-hand experience with major regulatory programs and frameworks. 
Kellie Combs | Read Bio
Partner, Ropes & Gray LLP
KELLIE COMBS is a partner at Ropes & Gray LLP. She provides legal and strategic advice to pharmaceutical, biotechnology, and medical device manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Recognized as a “Rising Star” in Food and Drug Law by Super Lawyers, Kellie has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advises clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, Kellie has performed regulatory due diligence in connection with transactions involving life sciences clients and has advised on a number of government investigations of FDA-regulated companies. Kellie is an editor of the newly released FDLI publication, 
Moderated by
Joy Liu | Read Bio
VP, Commercial and Regulatory Legal, Vertex Pharmaceuticals, Inc., and Secretary and General Counsel, FDLI Board of Directors
JOY LIU leads the Commercial and Regulatory legal team at Vertex Pharmaceuticals. Prior to joining Vertex, Joy was a partner at Ropes & Gray and advised drug, biotech, and device companies on a broad range of FDA regulatory matters. She has significant experience working on advertising and promotion compliance matters, Hatch-Waxman exclusivity issues, and regulatory risk management. In private practice Joy also worked on a number of government investigations involving allegations of off-label promotion, “silent” recalls, inadequate safety reporting, and failure to comply with GMP/QSR. She also represented Pacira Pharmaceuticals in its lawsuit against the FDA, alleging violations of its First and Fifth Amendment rights as well as of the Administrative Procedure Act. Related Content
