FDA releases its latest batch of Warning Letters that include Kalchem International, Mayons Pharmaceuticals and Silkprousa.
FDA warns Sprout Pharmaceuticals about a violative radio ad for Addyi, indicated for women with low sexual desire.
FDA warns Kalchem International about new and repeated CGMP violations and deviations in its production of finished drugs and APIs.
Federal Register notice: FDA issues a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaftor), indicated for ...
Federal Register notice: FDA makes available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Indus...
Federal Register notice: FDA posts a list of information collections that have been approved by OMB under the Paperwork Reduction Act of 1995.
FDA publishes a draft guidance with updated recommendations for including geriatric information in the labeling for prescription human drugs and biolo...
FDA warns Indias Mayons Pharmaceuticals about CGMP issues in its manufacturing of finished drugs and APIs.