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


Office of Reg Affairs reorg

Executive Summary

FDA's Office of Regulatory Affairs will realign the workload of the two remaining deputy associate commissioners for regulatory affairs following the departure of Deputy for Regulatory Operations Steve Niedelman. Deputy ACRA Diana Kolaitis will "take lead responsibility for the operational aspects of ORA's work, including the achievement of our inspections and laboratory work," the agency said June 22. The director of the Office of Regional Operations will report to Kolaitis. Deputy ACRA David Horowitz will lead strategic aspects, including setting priorities and developing policies, with the director of the Office of Enforcement reporting to him. Niedelman leaves FDA at the end of June to take the role of exec VP at Quintiles Consulting (1"The Pink Sheet" June 19, 2006, In Brief)...

You may also be interested in...

From FDA to Quintiles

Steven Niedelman, former FDA deputy associate commissioner for regulatory operations, joined Quintiles Consulting as executive VP, the firm announced Aug. 2. Upon his departure from the agency Deputy ACRAs Diana Kolaitis and David Horowitz assumed his duties (1"The Pink Sheet" June 26, 2006, In Brief). Niedelman replaces Ron Johnson, who has moved on to Quintiles subsidiary The Lewin Group, a healthcare and human services consulting firm...

QUOTED. 28 September 2020. Kyle Sampson.

If President Trump appoints, and the Senate approves, a new conservative justice for the Supreme Court to replace Ruth Bader Ginsberg, Affordable Care Act coverage could disappear. See what Kyle Sampson, a partner with the Washington, DC law firm King & Spalding said about it here.

Quick Listen: Scrip’s Five Must-Know Things

Join us for an audio roundup of major events in the global biopharma industry over the past week, as reported by Scrip




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