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On Tuesday May 9, 2017 the Senate confirmed Scott Gottlieb to be the next head of the FDA. In order to provide a well rounded view of our new FDA Commissioner, we’ve provided excerpts and links to a diverse variety of stories as reported by FDA, Reuters, The New York Times, and RAPS Regulatory Focus:…
May 15, FiercePharma reported “White House budget director suggests rebate mandates for Medicare to cut drug prices.” The story states in part that “The industry’s response was immediate and definitive in its opposition. “Any type of government price-setting in Medicare Part D would limit access to needed medicines and increase costs for beneficiaries,” PhRMA spokeswoman…
According to FDA on May 2, “A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially road maps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has…
WorldPharmaNews reported on May 12 that “Alzheimer’s experts call for changes in FDA drug approval standards”: “Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease,” urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new…
On April 24, 2017, Health Canada reported that “In efforts to stay aligned with other regulatory authorities, in July of 2016, Health Canada announced January 1st, 2018 as the proposed date for mandatory filing of specified regulatory activities in eCTD format. This notice serves as a confirmation of this date…Please be advised that exemption from…