CDRH posts a list of final and draft guidances it expects to publish in FY 2024.
While denying a Parenteral Technologies petition to force a change in pediatric acetaminophen directions for use, FDA says it is planning a safety ord...
The Justice Department says Magellan Diagnostics has been ordered to pay $42 million in fines, forfeitures, and compensation after pleading guilty to ...
FDA approves Genentechs Itovebi to be used with two other drugs to treat some breast cancers identified through a diagnostic test.
FDA approves an IDE for Iota Biosciences to conduct a feasibility study of its investigational implantable device designed to deliver electrical stimu...
Attorneys at Hogan Lovells say (XXX DELETE s XXX)that a final guidance on electronic records and systems used in clinical trials includes a broader sc...
Teva Pharmaceuticals agrees to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Statute and the False Cl...
Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act hits its 11/27 impl...
