FDA’s New Enforcement Strategy

Enforcement strategies. Inspections and recalls. Self-regulation and best practices. New whistleblowing policies. New data you’re required to collect and maintain. What “quality” will mean going forward. All that — and more — will be revealed Thursday, March 23, 2017, at this top-level sit-down with the men and women who oversee your drugs and devices.

You’ll hear the latest thinking from these invited speakers and/or their deputies:

  • Office of Regulatory Affairs (ORA): Melinda Plaiser, Director
  • Center for Devices & Radiological Health (CDRH): Robin Newman, Director-Compliance
  • Center for Drug Evaluation & Research (CDER): Janet Woodcock, Director

And you’ll discover:

     ✓New FDA enforcement initiatives that could affect your market position ...
     ✓New thinking on FDA penalties and how to avoid them ...
     ✓New approaches to reducing the likelihood of inspection visits ...
     ✓New information on the push for more structured whistleblowing  ...

Prepare to dive deep into regulatory policy details. Take the move to new “dashboards” and compliance tools. This shift in FDA direction is evolving so rapidly, many drug and device makers are having trouble keeping up. How are these new initiatives meshing, and what will the impact be on inspections and enforcement? Come to the briefing and find out.

  • For drugmakers, CDER has discussed a pilot dashboard program starting with generic drugs. How will this be applied to innovator products? And does the ORA endorse the approach?
  • For devicemakers, CDRH just announced a new whistleblower site. How will implementation take place? And how might it affect ORA enforcement priorities?

The event takes place in the conference rooms of McGuireWoods LLP, a top Washington law firm specializing in FDA regulatory matters. The host and moderator is Senior Counsel Brian Malkin, leader of the McGuireWoods FDA regulatory team and a co-editor of the FDA Life blog covering news and trends affecting the FDA and life science industries.

Every presidential election is a turning point, this one maybe more than any other. You owe it to your colleagues — and to yourself — to come to Washington now and make ready for all the uncertainties and unknowns that may lie ahead.

Register by March 3 and $AVE $200!