Federal Register notice: FDA issues a final rule to classify in vitro diagnostic devices for Bacillus species detection into Class 2 (special controls...
Federal Register notice: FDA issues a final rule to classify posterior cervical screw systems into Class 2 (special controls) and to continue to requi...
Federal Register notice: FDA amends the medical device reports of corrections and removals regulation to correct three inaccurate cross-references.
Legislation introduced by Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) seeks to make permanent a new FDA policy that was put in place in December to...
FDA approves a Merck EMD Serono NDA for Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis in adults.
FDA approves a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressairs (aclidinium bromide inhalation powder) prescribing info...
The Federal Trade Commission releases an opinion and final order against generic company Impax Laboratories, finding that it engaged in an illegal pay...
Federal Register notice: FDA proposes to amend and repeal parts of its radiological health regulations covering recommendations for radiation protecti...