FDA medical reviewers question the efficacy of Alnylam Pharmaceuticals patisiran for an expanded population sought in an sNDA.
FDA publishes its FY 2022 report on GDUFA science and research outcomes.
FDA warns Safecor Health that its Columbus, OH-based drug manufacturing facility has significant violations of CGMP requirements for finished drugs.
FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CGMP violations.
FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.
CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to protect public health du...
A Presidents Council of Advisors on Science and Technology report on patient safety includes two recommendations for FDA action.
A white paper by the Duke Margolis Center for Health Policy calls for a new government coordinating effort, the Prevent Drug Shortages Initiative, to ...
