Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Deputy commissioner leaving FDA

This article was originally published in The Tan Sheet

Executive Summary

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

QUOTED. 28 February 2020. Jubilee Brown.

Laparoscopic power morcellation to remove uterine fibroids should only be performed with the use of a compatible containment system, and only on women younger than 50, the US FDA said in a newly published safety communication and draft guidance document. See what the president of the gynecologic trade group AAGL, Jubilee Brown, said about it here.

Topics

UsernamePublicRestriction

Register

PS100045

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel