Listing of Recent Information Collections Approved by OMB
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. To view the notice, click here.
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FDA Prediction Markets Could Undermine Reviews, Trials: Researchers
The growing use of online prediction markets Kalshi and Polymarket to wager on clinical trial outcomes and FDA drug approvals could compromise trial integrity, encourage insider trading, and undermine public confidence in regulatory decisions, three Boston University researchers warned. Kalshi launched a pilot program in July (see earlier story) allowing
Unions Accuse FDA of Violating Employees’ First Amendment Rights
Two federal employee unions have accused FDA of violating employees’ First Amendment rights by prohibiting off-duty union activities and restricting the use of agency computers and networks for union-related communications. In a 10/9 letter to FDA acting commissioner Kyle Diamantas and chief operating officer Melanie Keller, the
FDA Launches Rare Disease Framework Initiative
FDA says it is launching a Rare Disease Framework Initiative “to reimagine the development of drugs and biologics for rare diseases.” In a statement, which includes a link to a new white paper on the initiative, the program will “develop an optimized, fit-for-purpose framework that reflects the realities
Container Closure System Guidance Comments
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s attention to container closure systems in light of the significant technological advances that have emerged in material science and drug delivery systems since the agency’s 1999 guidance on the same topic. In a comment letter on an