Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 30 April 2013 | By Ansis Helmanis
The US Food and Drug Administration (FDA) announced today that one of its top regulatory officials, Deborah Autor, deputy commissioner for the office of Global Regulatory Operations and Policy (GO), will be leaving the agency shortly to join Mylan Pharmaceuticals.
Autor's departure is at least the third major staff shakeup in recent days. Yesterday, FDA announced the hiring of a new Deputy Commission for Policy, Planning and Legislation, Sally Howard, and a new director of the Office of Executive Programs, Mary Beth Clark.
In a memo sent to all staff on Tuesday, 30 April 2013, Hamburg told staff that Autor will be joining Mylan as Senior Vice President, Strategic Global Quality and Regulatory Policy.
"Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her." FDA Commissioner Margaret Hamburg wrote. "Deb's last day at FDA will be 1 June 2013." Autor has been with FDA for more than 11 years, and currently oversees around 4,400 staff at GO.
In a statement released by Mylan Pharmaceuticals, Autor said she was looking forward to joining the company. "Mylan has been a leading advocate for ensuring one quality standard, both internally and externally, as evidenced by the company's active role in the development and passage of the FDA Safety and Innovation Act, or FDASIA," she said, according to the statement. "I am very excited to be joining an organization whose people demonstrate such extraordinary passion and commitment to quality and access to medicine. I look forward to contributing to Mylan's continued leadership on quality - both from an operational and policy perspective."
Stepping up for Autor in the interim will be John Taylor III, counselor to the commissioner, who will serve as the chief of GO while the agency searches for a permanent replacement.
Read all Breaking News from RegLink
Read all Regulatory Focus stories on Deborah Autor
is with mixed emotions that I write to inform you of the upcoming departure of
Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and
Policy (GO), after 18 years of dedicated federal government service, including
11 years spent here at FDA.
has overseen various critical programs within the Agency including, most
recently, the GO Directorate. In that role, Deb has led the
implementation of FDA's strategy for addressing the challenges of globalization
and import safety, including the paradigm shift that FDA must make to meet the
challenges of globalization today and in the future through global coalitions,
global data systems, advanced risk analytics, and leveraging of the efforts of
public and private third parties. Deb has outlined a strong vision for GO
that focuses on being data-driven, strategic, and risk-based, moving towards a
stronger global product safety net to advance and protect public health. Prior to assuming the role of Deputy Commissioner,
Deb worked in several critical positions within the Office of Compliance in
FDA's Center for Drug Evaluation and Research (CDER), including for five years
as its Director.
is leaving the Agency to take the position of Senior Vice President, Strategic
Global Quality and Regulatory Policy at Mylan, Inc. Please join me in wishing
Deb all the best as she and her family relocate to the Pittsburgh area and
embark on this new endeavor. While I am sad to see Deb go, I am happy
that she has found this terrific opportunity. Deb has demonstrated great
leadership, creativity, and passion for public health throughout her FDA
career, and we will miss her. Deb's last day at FDA will be June 1,
pleased to announce that John M. Taylor, III, currently the Counselor to the
Commissioner, has graciously agreed to serve as Acting Deputy Commissioner for
Global Regulatory Operations and Policy in the short term starting May 18 as we
look for a permanent replacement for Deb.
A. Hamburg, M.D.
of Food and Drugs