Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Lenvima (lenvatinib mesylate) is 3,580 day...
Four House committee leaders ask FDA for a contingency response plan addressing their concerns over the risk of worsening U.S. shortages of heparin du...
A 2/2 letter to FDA from 92 bipartisan members of the U.S. Senate and the House urges the agency to use all tools at its disposal to address the dire ...
CDRH director Jeff Shuren says that consumers should not be alarmed about findings from a new rodent study evaluating cell phone or radiofrequency ene...
Attorney Riette van Laack describes legislation to reform FDAs over-the-counter drug monograph system and allow for user fee funding.
FDA and 15 other federal agencies issue a new framework for drug toxicity testing to obtain more relevant human data and reduce animal testing.
Yale University researchers say loopholes in the FDA dermatologic device review process allow potentially dangerous changes without adequate evaluatio...
FDA orders a Boxed Warning on Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) after determining that it is being incorrectly d...