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  • Regulatory NewsRegulatory News

    Pfizer Appoints Gottlieb to Board of Directors

    Following in the tradition of recently departed US Food and Drug Administration (FDA) commissioners, Scott Gottlieb is joining the board of directors at Pfizer. In addition to his role on the Pfizer board, Gottlieb, an elected member of the National Academy of Medicine, is also resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates. Reactions to Gottlieb’s decision to join the Pfizer board ranged from ...
  • Regulatory NewsRegulatory News

    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...
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    Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

    As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach." Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic dru...
  • Regulatory NewsRegulatory News

    Former FDA and NIH Heads Call for Regulatory Harmonization

    Former US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and former National Institutes of Health (NIH) Director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine . The call comes as nearly 40% of drugs and half of all medical devices used in the US are made elsewhere, while 80% of the active pharmaceutical ingredients in US drugs are manufactured in f...
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    Senators Hint at Confirmation of Califf as Next FDA Commissioner

    Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...
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    President Obama Nominates Califf as Next FDA Commissioner

    President Barack Obama has nominated Robert Califf, the current deputy commissioner for medical products and tobacco at the US Food and Drug Administration (FDA), as the next commissioner of the agency. Califf's History Califf joined the FDA back in February following a stint as vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DT...
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    Former FDA Commissioner Steps Into New, Internationally Focused Healthcare Role

    Margaret Hamburg, the former commissioner of the US Food and Drug Administration (FDA), may have stepped down from her role as commissioner earlier this week, but that doesn't mean she's stepping away from government service or healthcare just yet. This week, the Institute of Medicine (IOM) announced that Hamburg has accepted a position as the foreign secretary of IOM. The part-time position will allow Hamburg to service "as a senior adviser on international matters to t...
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    Charts: Who are the Longest-Serving Commissioners in FDA History?

    On 5 February 2015, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced she would resign from her position in March 2015. This caused us to wonder: How long will Hamburg have served when she steps down from her position, and how does that compare with other FDA Commissioners before her? As we found, Hamburg will be the sixth-longest serving Commissioner in FDA history, and the second-longest-serving commissioner of the modern regulatory era...
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    FDA Commissioner Margaret Hamburg to Resign Next Month

    Margaret Hamburg, one of the longest-serving commissioners in US Food and Drug Administration (FDA) history, plans to announce her resignation tomorrow, FDA officials have confirmed to Regulatory Focus . Hamburg's final day at the agency will be in late March 2015, Hamburg wrote in an email. She will be succeeded on an acting basis by Stephen Ostroff , FDA's chief scientist since January 2014 . A Long Tenure Hamburg's resignation brings to an end one of the longest ...
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    Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

    The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials. Background FDA made headlines earlier this month when it announced that it had found vials of variola —the virus which caus...
  • FDA Officials are Frequent Visitors to White House, Data Show

    Ever wonder how much influence the US Food and Drug Administration's (FDA) top regulatory officials have with the highest executive office in the land, the White House? If you buy the theory that access is tantamount to influence, the agency seems to have a good amount of it. Focus recently combed through four years of the White House's public visitor logs, querying the data to find instances in which some of FDA's top officials met with the president's staff, either a...
  • Global Healthcare Product Regulators in Talks to Form New Regulatory Supergroup

    US and international regulators are reportedly working to form a new global regulatory organization focused on leveraging and sharing resources and information among regulatory authorities. The existence of the organization was announced this week in London by US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, who was attending the Medicines and Healthcare Products Regulatory Agency's (MHRA) ninth Annual Lecture. "Regulators around the world have begun...