Deputy commissioner leaving FDA
This article was originally published in The Tan Sheet
Scott Gottlieb, MD, the agency's Medical & Scientific Affairs exec, announces Dec. 12 he will leave to return to the American Enterprise Institute think tank, where he was a resident fellow before joining FDA 18 months ago. He has worked on FDA policy initiatives, including improving the advisory committee process and improving the effectiveness of the agency's approaches to communicating risk information to the public. Gottlieb, who practiced internal medicine during his tenure as a public official, also helped facilitate implementing new regulations and policies, including drug and biologic products labeling and expanded access to drugs under development. Gottlieb, who is leaving FDA effective Jan. 16, 2007, commented this year that technological changes in the drug marketplace will prompt changes in the approval process for nonprescription products and will lead to opportunities for development of new OTCs, particularly for chronic conditions (1"The Tan Sheet" May 8, 2006, p. 4)...
You may also be interested in...
FDA Deputy Commissioner
FDA announces Dec. 21 Randall Lutter, Ph.D., will serve as acting deputy commissioner for policy. The agency says Lutter will "provide guidance and input on all agency matters and serve as lead adviser to the commissioner on agency policy." Lutter most recently served as FDA's associate commissioner of policy and planning "where he coordinated the agency's regulatory and administrative policies aimed at protecting and advancing the health of the public," the agency says. Lutter will replace Scott Gottlieb, M.D., who announced Dec. 12 he will leave FDA to join the American Enterprise Institute think tank (1"The Tan Sheet" Dec. 18, 2006, In Brief)...
Future OTC Technologies Will Bring Regulatory Challenges – Gottlieb
Technological changes in the OTC drug marketplace will prompt changes in the approval process for nonprescription products, according to FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, MD
HHS Watchdog Blesses Proposed Gift Card Giveaway To Encourage Test Returns
A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.