Falls Church, VA (PRWEB)
September 25, 2017
FDAnews Expert Insight Series:
Device Regulation Under Gottlieb & Trump
**An FDAnews Webinar**
Oct. 12, 2017 — 1:30 p.m. – 3:00 p.m. ET
FDA Commissioner Scott Gottlieb is off to a running start. Just look what’s happened in four short months:
The first device recall over cybersecurity (a pacemaker)
- Final guidance re: device interoperability
- New guidance re: use of real-world experience in device approvals
- New small-business guidance re: applying for lower user fees
- Clarification of early feasibility study program for early-stage devices
And Gottlieb is just getting started.
- His big-picture approach to device regulation has yet to emerge, as does
- What role patients will play in device development and approval, and
- How the FDA will sort out knotty issues surrounding combination products.
FDAnews’s expert panelists are ready with answers.
Mark the calendar for Thursday, Oct. 12 and Part II of the standout FDAnews Expert Insight Series. Attendees will hear from five of the most insightful FDA experts at work today as they track the path of the Gottlieb FDA and medical device regulation:
- 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 McClellan among 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-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…