Venable attorney Robert Schwartz says an updated FDA guidance with alternatives to switching studies for demonstrating biosimilar interchangeability i...
FDA warns Indias Sun Pharmaceutical Industries about repeat CGMP violations at one drug manufacturing facility and in other company facilities.
Attorneys in several law firms analyze the opportunities and risks for FDA-regulated companies arising from the Supreme Court decision to overturn Che...
FDA warns the ozempen.com Web site to stop offering unapproved and misbranded drugs to U.S. consumers.
FDA approves Lillys Kisunla injection to treat Alzheimers disease.
Five Hogan Lovells attorneys analyze a new FDA draft guidance on clinical trial diversity action plans and urge companies to begin planning now to imp...
FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational pharmacoepidemiologic...
CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the Division of Ophthalmi...
