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    FDA News

    • As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013

      By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …

    • New Director Tapped to Head FDA’s Office of Generic DrugsJuly 13th, 2012

      By Kurt R. Karst – FDA’s Office of Generic Drugs (“OGD”) will have a new leader beginning next week.  On July 13th, Helen Winkle, Director of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research, in which OGD is housed, announced that Gregory …

    • Drop the “Acting” – FDA’s Liz Dickinson is Named Chief CounselMarch 1st, 2012

      On February 29th, FDA Commissioner Margaret A. Hamburg, M.D. announced in an FDA-wide e-mail the permanent appointment of Elizabeth H. Dickinson as FDA’s Chief Counsel.  Ms. Dickinson has served as FDA’s Acting Chief Counsel since August 7, 2011 (see our previous post).  Prior to that …

    • Lawyer, Physician, and Bioethicist Takes Over the Reins at FDA’s Orphan Drug ShopOctober 6th, 2011

      By Kurt R. Karst –       We have learned that FDA’s Office of Orphan Products Development (“OOPD”) has a new Acting Director.  Debra Lewis, O.D., M.B.A., who is OOPD Deputy Director, and who has been serving as Acting Director since the Departure of Dr. Timothy Coté earlier …

    • FDA’s Elizabeth H. Dickinson Tapped to Serve as Acting Chief CounselJuly 12th, 2011

      FDA Law Blog has learned that Elizabeth H. Dickinson, who currently serves as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, will serve as FDA’s Acting Chief Counsel effective on August 7th.  As we previously reported, FDA’s current Chief Counsel, Ralph Tyler, recently …

    • FDA’s Chief Counsel, Ralph Tyler, Set to Leave FDAJune 30th, 2011

      About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg.  Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of …

    • Change Is In The Winds At DOJJune 20th, 2011

      By John R. Fleder – For over forty years there has been a unit in the Department of Justice dedicated to representing FDA in court actions.  Originally housed in the Antitrust Division under the name "Consumer Affairs Section", the office was moved to DOJ's Civil Division …

    • FDA’s June Stephenson Retires After 37 Years in FDA’s Office of Chief CounselDecember 12th, 2010

      June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010.   Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974.  At a December 8th retirement party, her contributions were recognized by almost all …

    • FDA Announces a New Class-Wide REMSFebruary 18th, 2010

      By William T. Koustas —  The FDA has announced that it will require all drugs known as Erythropoiesis-Stimulating Agents (“ESAs”) to have a Risk Evaluation and Mitigation Strategy (“REMS”).  At the present time, this class of drugs is limited to three Amgen products: Procrit, Epogen (both …

    • FDA Announces New Chief Counsel – Ralph S. TylerDecember 16th, 2009

      By Kurt R. Karst –       Earlier today, FDA Commissioner Dr. Margaret Hamburg announced in an Agency-wide e-mail that Ralph S. Tyler has been appointed to serve as FDA’s Chief Counsel.  Mr. Tyler, who is currently serving as Insurance Commissioner of the State of Maryland, will …

    • FDA Establishes Task Force to Increase Transparency; Will Hold June 24th Meeting to Gather ViewpointsJune 3rd, 2009

      By Jamie K. Wolszon –  FDA has announced the establishment of a cross-agency task force to craft recommendations on how to increase transparency regarding the agency’s operations, activities, processes and decisionmaking, including product approvals, enforcement actions, and product recalls, while protecting confidential information.  The agency …

    • U.S. Senate Confirms Dr. Hamburg as 21st FDA CommissionerMay 18th, 2009

      By Kurt R. Karst –       On May 18th, the U.S. Senate confirmed (by voice vote) President Obama’s pick to head FDA – Dr. Margaret Hamburg.  Among other things, Dr. Hamburg has worked extensively on bioterrorism issues.  For six years in the 1990s, Dr. Hamburg served …

    • Michael M. Landa Tapped as Acting FDA Chief CounselApril 9th, 2009

      By Kurt R. Karst –       We learned earlier today that Michael M. Landa, Esq. was named as FDA’s new Acting Chief Counsel.  Mr. Landa, who will assume his new role on April 13, 2009, has a long history with FDA.  Since July 2004, Mr. Landa …

    • President Announces New FDA Commissioner and Principal Deputy Commissioner, and Pledges to Toughen Food Safety LawsMarch 16th, 2009

      By Ricardo Carvajal–       In an address highlighting the need to tackle problems with the nation’s food safety system, President Obama today announced the appointments of Dr. Margaret Hamburg as the new FDA Commissioner and Dr. Joshua Sharfstein as Principal Deputy Commissioner with primary responsibility for …

    • New Guidance Documents Available for When Subjects Withdraw from Clinical TrialsDecember 9th, 2008

      By Susan J. Matthees— FDA and the Department of Health and Human Services Office for Human Research Protections (OHRP) recently announced the availability of two guidance documents intended to help investigators, researchers, sponsors, and IRBs understand how data already collected may be used after a …

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