The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.
The Feb. 8 U.S. drug pricing hearing before the Senate Health, Education, Labor and Pensions Committee started out as a spectacle in which Chair Bernie Sanders (I-Vt.) rehashed his usual talking points as he lectured the CEOs of Bristol Myers Squibb Co., Johnson & Johnson and Merck & Co. Inc. about how their companies charge so much more for their drugs in the U.S. than in other countries. But despite the show-trial aspects of the hearing, or what Ranking Member Bill Cassidy (R-La.) called Sanders’ ongoing “CEO-whack-a-mole” agenda, some facts came through that could lead to pricing reforms if Congress has the bipartisan will to do so.
Shadowed by prescription drug shortages at their highest level since 2014, the FDA issued a slightly revised version Feb. 6 of a draft guidance it released a year ago to give it more visibility into the U.S. drug supply chain.
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment, as a qualified drug development tool.
When the House Energy and Commerce’s Subcommittee on Oversight and Investigations held its last hearing on the U.S. FDA’s foreign drug inspection program in December 2019, there were “reasons for cautious optimism,” subcommittee Chair Morgan Griffith (R-Va.) said in opening a Feb. 6 hearing on the issue. But in the wake of the pandemic, the optimism is gone.
Court rulings favoring biopharma companies that have challenged the U.S. Department of Health and Human Services’ efforts to force them to unconditionally offer 340B prescription drug discounts to an unlimited number of contract pharmacies could become moot in the future if a bipartisan draft bill becomes law.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said Jan. 30.
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court.
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