From White House To White Oak: US FDA Taps Stacy Cline Amin For Chief Counsel Post
The agency’s new top lawyer brings deep knowledge of FDA regulatory and legislative matters from her time on Capitol Hill and strong ties to the White House, where she has worked as special assistant and senior associate counsel to President Trump since early 2017.
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US FDA’s Lowell Schiller Steps In As Acting Chief Counsel When Rebecca Wood Departs In July
A permanent successor to Wood, who will have held the agency's top legal post for only a year, will be announced in the near future, FDA Commissioner Gottlieb says; in the interim, Schiller, senior counsel to the commissioner and a former Senate HELP Committee staffer, will lead the chief counsel's office on an acting basis.
US FDA Gets A New Lawyer: Rebecca Wood Named Chief Counsel
Former Sidley Austin partner brings a wealth of experience in drug product liability litigation and federal preemption. She replaces agency veteran Elizabeth Dickinson, who will stay on as senior deputy to the chief counsel.
Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.