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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

    Who's Actually Using 'Right-To-Try' Laws? A Texas Oncologist Explains his Experience

    What do a former prosecutor living in Arizona and unexpectedly diagnosed with neuroendocrine tumors by a specialist at the Mayo Clinic and referred for treatment in Switzerland, a Coloradoan who was also diagnosed and referred to Switzerland for treatment, and a Los Angeles-based lawyer who tried to get into immunotherapy trials but was denied have in common? They all say they obtained treatment from a Houston-based oncology center that has extended their lives than...
  • Regulatory NewsRegulatory News

    New Texas Law on Stem Cell Treatments: Showdown With FDA Coming?

    With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products. Similar to the “Right to Try” laws spreading across the US and attempting to undercut FDA’s regulation of investigational products, the Texas law , which had been brewing in some form since...
  • Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

    The state of Texas approved new-and controversial-rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Times . The changes, instituted 13 April by the Texas Medical Board, were reportedly spearheaded by Texas Governor and former Republican presidential nominee Rick Perry, who has said he experienced relief from the procedures, reports The Times . Some researchers, however, are ...