• Regulatory NewsRegulatory News

    FDA Launches New Drug Quality Office, With Goal of Improving the Pharmaceutical Industry

    More than two years after first proposing the creation of a quality-focused office, the US Food and Drug Administration (FDA) has finally launched its new Office of Pharmaceutical Quality (OPQ) in a bid to standardize and centralize how drug quality is overseen by regulatory officials. Background The creation of OPQ was first announced in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research (CDER) by longtime director Janet Wood...
  • RAPS' LatestRAPS' Latest

    FDA’s Woodcock Talks About Advancing Innovation at 2014 RAPS

    During the first day of 2014 RAPS: The Regulatory Convergence on 29 September 2014, Janet Woodcock, director of the US Food and Drug Administration’s Center for Drug Evaluation and Research spoke to attendees via a pre-recorded video. Woodcock covered some important initiatives and changes in drug development and regulation and the importance of finding more efficient ways to present clinical evidence to help translate medical innovations into therapies more quickly. Sh...
  • Regulatory NewsRegulatory News

    After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership

    The US Food and Drug Administration's (FDA) long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today. Background Since late 2012, FDA has been planning to elevate OGD to a so-called "Super Office"—an office which reports directly to the director of the Center for Drug Evaluation and Research, a position now held by longtime Director Janet Woodcock. OGD was previously a sub-office of the Office of...
  • Woodcock to Legislators: FDA Has Limited Role to Play in Advancing Manufacturing

    What role does the US Food and Drug Administration (FDA) have to play in promoting advanced manufacturing in the United States, if any? Manufacturing Hearing In a 12 December 2013 hearing before the House Committee on Oversight and Government Reform, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), argued that while manufacturing may be shifting overseas, the factors behind those moves have less to do with FDA than with market-driven...
  • House Legislators Set to Grill FDA on FDASIA Progress

    It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing? Background: FDASIA's User Fee Provisions FDASIA , passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms. To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescripti...
  • Woodcock: Reports of my Retirement Plans Greatly Exaggerated

    Reports of the demise of her employment status are greatly exaggerated, Janet Woodcock wrote in a memo to staff and the press on 10 October 2013 after a report in Reuters triggered confusion over whether the center director planned to retire next year. An Impactful Career The Reuters story, written by long-time life science industry reporter Toni Clark, explored Woodcock's influence within the Center for Drug Evaluation and Research (CDER), FDA's primary center f...
  • Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace

    US regulators strongly support plans to introduce a pharmaceutical track and trace plan, the US Food and Drug Administration's (FDA) top drug regulatory official told legislators in testimony on Thursday. Speaking before the House Energy and Commerce Committee's Subcommittee on Health on 25 April 2013, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), sought to answer legislators' questions regarding a long-standing question: What should the...
  • Citing Differences, FDA Generics Director Greg Geba to Resign

    The US Food and Drug Administration's (FDA) Director of the Office of Generic Drugs (OGD), Greg Geba, will resign effective 15 March 2013 over disagreements regarding his vision for the office, the agency wrote in an email to its internal staff. Background The departure comes just months after Geba took the position. In July 2012, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), announced the hiring of Geba from Sanofi, where he served as ...
  • Woodcock: FDA to Consider Approving Some Drugs Using Just One Phase I Clinical Trial

    Some innovative, high-need therapies could reach the market using just Phase I clinical trials data, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), explained, raising the prospect of unprecedented speed to market for some drugs. Woodcock's remarks, made at a Bloomberg -sponsored healthcare conference on 11 February 2013 and first reported by Bloomberg , pertain to the new breakthrough pro...
  • US Regulators Revoke Unique Exemption from Compounder in Wake of Concerns

    US Food and Drug Administration (FDA) officials have sent to a letter to one of the country's largest pharmaceutical compounders, reprimanding it for what they say are deviations from the terms of an agreed-upon plan that allowed it to operate more like a manufacturer, but with special conditions. Background The manufacturer, Illinois-based PharMEDium, had established a program with FDA in 2005 that allowed the company to compound drugs wholesale, and later on link thos...
  • Woodcock Proposes Manufacturing 'Scorecard' to Promote Consumer Awareness of Quality

    A new paper published in the journal Clinical Pharmacology & Therapeutics by two of the US Food and Drug Administration's (FDA) top drug regulatory officials argues that the market seems unable or unwilling to demand or accept regulatory quality, which has in turn led to increased shortages of sterile injectable drugs. Also proposed by FDA: a manufacturing scorecard, similar to restaurant scores, that could promote consumer awareness of quality. The paper, co-autho...
  • Woodcock Lauds First Submission of 'Breakthrough' Product

    The US Food and Drug Administration (FDA) has already accepted its first product under its new "Breakthrough" therapies designation, and more are soon to be on the way, a high-ranking agency official said recently. In a 3 December 2012 announcement posted on FDA's Voice blog, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), sought to explain the law, calling it an exciting development for an agency that has long searched for effective...