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    FDA Urges Caution With Neurosurgical Head Holders Due to Slippage

    The US Food and Drug Administration (FDA) issued a safety notice Thursday on the use of neurosurgical head holder (skull clamp) systems, which secure the patient’s head during surgical procedures. From January 2009 to January 2016, the agency said it received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries, though the review did not find ...
  • Focus on OIRA, Regulator of Regulatory Agencies, as Obama Prepares for Second Term

    What's next for the White House's Office of Information and Regulatory Affairs (OIRA)? The agency, a sub-agency of the Office of Management and Budget (OMB), is sometimes referred to as the regulator of regulators; the agency charged with reviewing regulations promulgated by other agencies to ensure they meet federal guidelines and are generally cost-effective and minimally burdensome. That mission has made it the bane of more than a few regulatory agencies, including ...
  • Skerritt Takes Reins as New Head of TGA

    Australia's Therapeutic Goods Administration (TGA) announced on 1 June the confirmation of Dr. John Skerritt as the new National Manager of the agency, ending a month-long lead-up process. Skerritt replaces Dr. Rohan Hammett, who resigned from the agency in December 2011 , and comes to the agency in the midst of a tremendous reorganization to combine the regulatory authorities of Australia and New Zealand into a single trans-national regulatory authority known as the ...
  • TGA Announces New Head of Agency

    Australia's Therapeutic Goods Administration (TGA) announced it has appointed Dr. John Skerritt, previously the Deputy Secretary of the Department of Primary Industries in the Victorian government, as the new national manager of TGA. In a statement posted on the agency's website on 2 May, TGA said Skerritt will take control of the agency at the end of May 2012 and said Skerritt is highly qualified to run the agency well. "Skerritt currently leads more than 1200 staff (i...
  • AstraZeneca CEO Out as New J&J CEO Takes the Helm

    • 26 April 2012
    Two life sciences giants are experiencing transitions in leadership, as AstraZeneca's Chief Executive Office David Brennan announced he was relinquishing his position effective immediately and incoming Johnson & Johnson (J&J) CEO Alex Gorsky assumes his position at the company on 26 April. Rumors of Brennan's departure have been brewing for some time, but finally came to a head after the firm announced a 19% decrease in first-quarter profits, reports Reuters . T...