• Woodcock Announces New Leader for CDER Compliance Office

    One of FDA's top pharmaceutical regulatory officials is getting a promotion. In an email sent to staff on Wednesday, 28 November, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), announced the promotion of Howard Sklamberg, JD, to the position of director of CDER's Office of Compliance (OC). Sklamberg will assume the OC position on 14 January 2013, Woodcock wrote. He currently serves as deputy associate commissioner for regulatory affair...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • Woodcock Proposes Creation of Generics Super Office, New Office of Drug Quality

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing for the likely elevation of the Office of Generic Drugs (OGD) to a new 'Super Office' in which a number of other CDER offices would be contained. "I am proposing to elevate the Office of Generic Drugs (OGD) to a 'Super Office,'" wrote Janet Woodcock, director of CDER, in an email to FDA staff on 7 September. "As a 'Super Office,' OGD would report directly to me, as do ...
  • FDA Gets Permanent Director for Reorganized Surveillance 'Super Office'

    The US Food and Drug Administration (FDA) has announced the promotion of Gerald Dal Pan, MD to the position of permanent director of FDA's Office of Surveillance and Epidemiology (OSE), where Dal Pan had been serving as acting director. OSE had recently undergone a reorganization that transformed it from a relatively minor office within the Center for Drug Evaluation and Research (CDER) and into a so-called "super office." Dal Pan has served as the head of OSE since 2005...
  • FDA Approves New Breast Cancer Drug Despite Manufacturing Concerns

    Genentech's application for Perjeta (pertuzumab ) won marketing approval from the US Food and Drug Administration (FDA) on 8 June, bringing to market a new-and expensive-biologic product for the treatment of advanced breast cancer. Perjeta is a humanized monoclonal antibody, and works in conjunction with Herceptin (trastizumab) to further reduce the growth of HER2-positive cancerous cells in breast cancer patients. The HER2 gene is associated with approximately 20...
  • FDA Employees Shed Insight on Agency's Activities, Goals

    Employees of the US Food and Drug Administration (FDA) have had a busy week (23-27 April), speaking at a wide range of events and venues. Regulatory Focus is happy to bring you a brief recap of their remarks in one centralized location. Margaret Hamburg, Commissioner, FDA : Hamburg said at a conference this week she experts this year to be "a landmark year" for legislative improvements to FDA's authority, but said it remains "difficult to predict" what form l...
  • Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

    • 25 April 2012
    A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters ' AlertNet . Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years. The US Food and Drug Administrati...
  • Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in tracking postmarketing regulatory issues and has made significant advancements since 2008, reports Reuters . "Our oversight of the safety of marketed drugs has changed significantly over the past few years," said Woodcock in a statement. "This report shows that the quality, acco...
  • Drafts of PDUFA, MDUFA Released in House, Senate

    Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Drug User Fee Act (PDUFA) . The Senate Health, Education, Labor and Pensions (HELP) Committee's discussion draft, The Food and Drug Administration Safety and Innovation Act (FDASI) , comes before a 25 April hearing to reauthorize PDUFA , the Medical Device User Fe...
  • Woodcock Testifies on PDUFA, FDA Drug Approval Performance

    The US Food and Drug Administration's (FDA) top drug regulator, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, testified Friday, 30 March before the Senate Health, Education, Labor and Pensions (HELP) Committee to advocate for the expedited approval of the Prescription Drug User Fee Act (PDUFA) and to tout FDA's historical accomplishments and its path forward. Speaking on the PDUFA legislation, Woodcock said the legislation has "led to ...
  • Full Information From FDA OTC Switch Meeting Released

    The complete information from the 23 March over-the-counter switch meeting between the US Food and Drug Administration (FDA) and industry and public stakeholders has been made public. FDA is currently considering whether to create regulations that would make it easier for consumers to buy medications that are currently prescription-only. The so-called "over-the-counter (OTC) switch" would make some popular medications available OTC if they can be used safely with minimal...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...