In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement.
New device policies will have been established. New Trump-Gottlieb appointees will be taking their seats. Many new devices will have been approved. And it will be coming clear how fundamental standards for approval will differ from the past.
Perhaps most important, policies on product approvals and other key issues will be starting to emerge: Relationships between medical devices and combination products, fast-track approvals, clinical trials, and more.
Given the fluid nature of events though, panelists are certain to range beyond the topic of the day. Other installments include:
What We’ve Learned Since Scott Gottlieb Was Confirmed
Pharmaceutical Regulation under Gottlieb-Trump
The FDA Under Gottlieb-Trump and a Look Ahead
If you are a devicemaker, you know this is the must-attend session. But it makes sense to register for them all. Scott Gottlieb’s FDA is now your FDA.
Manufacturing – GMP/QSR/GCP
Clinical Trial Design
Meet Your Presenters
Wayne Pines, chief FDA spokesman for seven years. Mr. Pines was FDA Alumnus of the Year (2004). He now advises FDA-regulated clients on crisis communications ...
Peter Pitts, top policy adviser to FDA Commissioner McClellanamong other FDA leadership positions. While at the FDA Mr. Pitts worked directly with Scott Gottlieb. He now heads the Center for Medicine in the Public Interest ...
Marc Scheineson Esq., partner, Alston & Bird LLP. As FDA associate commissioner for legislative affairs, Mr. Scheineson was active on Rx user fees, debarment, medical device amendments and nutrition labeling, among other innovative policies. He has also served as a counsel to the House Ways & Means Committee ...
Jill Hartzler Warner Esq., VP of Regulatory Policy, Catalyst Healthcare Consulting. Over 30+ years as an international regulatory policy specialist, Ms. Warner held FDA leadership roles including Associate Commissioner, Senior Advisor, and Associate Chief Counsel. She oversaw policy on orphan products development, combination products, pediatric therapeutics, good clinical practice, regenerative medicine, and advisory committee oversight and management, among other responsibilities ...
Dan Kracov Esq., Partner, Arnold & Porter Kaye Scholer LLP. As one of the nation’s foremost FDA legal practitioners, Mr. Kracov is known for expertise in development, approval and marketing of FDA-regulated products — not only drugs and devices but also foods, dietary supplements and cosmetics ...