FDA launches a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting System.
FDA releases two documents and plans more steps to help drug compounders register as outsourcing facilities.
Hyman, Phelps attorneys say that a California federal court rejected a whistleblower suit against Medtronic over fraud-on-FDA and off-label promotion ...
FDA releases a FDA-483 issued to Aurobindo Pharma following an inspection at its Hyderabad drug manufacturing facility.
An online blog post looks at possible ways FDA could expand its approach to stem cell clinics marketing products the agency considers to be unapproved...
FDA grants Cascadian Therapeutics an orphan drug designation to tucatinib for treating HER2-positive metastatic colorectal cancer.
FDA clears a Fotona 510(k) for its new StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar rev...
FDA clears a Hologic 510(k) for the body laser contouring product SculpSure to treat a double chin (submental area).