Sidley attorneys say a new FDA final guidance on a risk-based approach to clinical trial oversight is significant for trial sponsors.
Generic mifepristone maker GenBioPro sues FDA to block the agency from taking any actions against the company if a pending court order under review by...
FDA approves an expanded indication for AbbVies Qulipta to prevent chronic migraines.
The U.S. Supreme Court extends by two days (until 4/21) its administrative stay of a lower courts 4/7 order that would restrict the distribution of th...
An ongoing European Medicines Agency and FDA joint initiative on information sharing involving generic drug bioequivalence study inspections adds Irel...
FDA grants traditional approval of Genentechs Polivy (polatuzumab vedotin-piiq) for combination use with four other drugs in for treating certain adul...
House Committee on Oversight and Accountability chairman James Comer begins probe into FDAs recent decision not to regulate cannabidiol products as di...
Federal Register notice: FDA announces an opportunity for public comments on an information collection extension entitled FDA Human Cells, Tissues, an...
