• Regulatory NewsRegulatory News

    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
  • Regulatory NewsRegulatory News

    Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave

    The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed. Uhl has served as head of OGD for two years, first as acting director starting in March 2013, and then as the office's permanent director in January 2015. Under her leadership, OGD has been implementing huge changes spurred by the passage of the Food and Drug Administration Safety and Innovati...
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    After Two-Year Search, FDA's Office of Generic Drugs Hires Permanent Leader

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD)—the office charged with overseeing and approving all generic drug products in the US—is finally getting a permanent leader, the agency has confirmed. Filling a Void In an email to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said the agency had decided to hire Kathleen "Cook" Uhl as the permanent director for OGD. Uhl had been serving as acting dire...
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    Immergut, FDA's Top Communications Official, Stepping Down

    The US Food and Drug Administration's (FDA) top communications official, Steven Immergut, is set to leave the agency next month to "pursue other opportunities," according to FDA officials. Immergut, who currently serves as acting associate commissioner for external affairs (EA), has been with the agency for three years, having joined the agency in 2011 as the assistant commissioner for media affairs. Immergut has been in his current position since December 2013, when he ...
  • Pressure Mounts on DHHS to Overturn FDA Decision on Zohydro

    A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...
  • Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

    Under normal regulatory procedures in the US, when a new drug is approved by the US Food and Drug Administration (FDA), its approval decision is the last word. But now in the wake of the agency's approval of a painkiller that critics say is dangerous, one senator is calling for US health officials to exercise a rarely used authority to overturn the decision. Background: Plan B Until December 2011, FDA had never before seen one of its decisions overturned. But shortly af...
  • BREAKING: Federal Judge Orders FDA to Make 'Plan B' Available Over the Counter to All Ages

    In a stunning reversal of a 2011 order by US Department of Health and Human Services Secretary Kathleen Sebelius, a federal judge has ordered the US Food and Drug Administration (FDA) approve an application by Teva Pharmaceuticals that would permit their Plan B (levonorgestrel) morning after pill to be made available as an over-the-counter product instead of by prescription, saying Sebelius likely lacked the authority to make such a decision, and that regardless of her au...
  • Sebelius Writes to Congress, Reminding Them of Sequester's Impact on User Fees

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration (FDA) under various legislative vehicles and agency programs are at risk under the sequester. Background On 1 March 2013, without intervention from Congress, all federal agencies (with the exception of the Department of Defense) will be subjected to an annualized 8% reduction ...
  • FDA Declines to Take Action Against Unusual 'Plan B' Distribution Scheme

    • 30 January 2013
    In the waning days of 2011, US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius conducted an unprecedented action when she ordered the US Food and Drug Administration (FDA) to overturn its finding that Plan B (levonorgestrel) would be safe and effective for over-the-counter use for those under the age of 17. But now FDA has signed off on an agreement that could soon see the pill being dispensed at an unusual location: vending machines. That d...
  • US Health Secretary to Remain in Second Obama Term

    • 10 January 2013
    In a widely expected move, US Department of Health and Human Services Secretary (DHHS) Kathleen Sebelius, an Obama Administration official who was appointed to the position in early 2009, will stay on in her position into at least the early parts of President Barack Obama's second term, The Hill reports . Sebelius would be among just a small handful of Cabinet officials who would be staying on through the second term. Both she and her department are in the midst of ...
  • FDA Given New Authority to Oversee Clinical Trials Data Reporting

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement . Under section 801 of the Public Health Service Act (PHSA) , as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institut...
  • Lawmakers: Reform 'Indefensible' Blood Donation Policy

    A group of 62 US lawmakers sent US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius a letter on 11 June expressing their collective support for a draft policy announced in March 2012 that would examine the feasibility of relaxing rules currently prohibiting gay men from donating blood or plasma. In DHHS's Request for Information on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for Men Who have Had Sex ...