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FDA Chief Counsel Addresses First Amendment, Enforcement

Executive Summary

US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.

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In June, US FDA gave manufacturers permission to discuss their devices in ways that strayed outside the official labeling language as long as they met certain standards. FDAers and lawyers discussed the practical implications of that rule at a recent conference in Washington DC.

US FDA Chief Counsel Rebecca Wood Steps Down

FDA will soon announce a permanent successor to Wood, who is leaving in July after about a year in the post, FDA Commissioner Gottlieb says. In the interim, Lowell 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’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.

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