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  • Regulatory NewsRegulatory News

    Trump Nominates Hahn to be FDA Commissioner

    President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US Food and Drug Administration (FDA) commissioner. If confirmed by the Senate, a process that could take several months, Hahn will take the reins of FDA from Acting Commissioner Ned Sharpless, who moved over to FDA following a stint as head of the National Cancer Institute (NCI). Sharpless will return to direct NCI, while Brett Gi...
  • Regulatory NewsRegulatory News

    FDA's 'TurboTax' Pilot Program for Medical Devices Expanding

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a ...
  • Regulatory NewsRegulatory News

    New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple

    A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance. CDRH Submission Tracker Pilot The Center for Devices and Radiological Health's (CDRH) pilot program, known as the CDRH Submission Tracker pilot, is an attempt to allow companies large and small to have a better sense of...
  • Cancer Center Announces $3 Billion Anti-Cancer Initiative, With Focus on Regulatory Challenges

    • 21 September 2012
    "We choose to go to the moon. We choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win, and the others, too." - John F. Kennedy, 25 May 1961 On 25 May 1961, US President John F. Kennedy's now-...