• 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 ...
  • 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...
  • 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 ...
  • UPDATED: FDA Completes Work on Three User Fee Acts, Sends to Congress

    Right on schedule , the US Food and Drug Administration (FDA) today confirmed that it has finished work on three user fee programs that will be sent to the Congress immediately. In a blog posting on the FDA Voice blog, FDA Commissioner Margaret Hamburg called the existing User Fee Acts "highly successful" programs that were responsible for "revolutionizing the drug approval process." Hamburg noted that Department of Health and Human Services Secretary Kathleen Sebe...