The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.
FDA releases the form FDA-483 with eight observations from an inspection at the Madhya, Pradesh, India-based Cipla facility that manufactures sterile ...
A Reuters investigative report relying on anonymous sources says FDA has rejected an application from Elon Musks Neuralink to open human trials of its...
A Senate bipartisan bill aims to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs.
FDA commissioner Robert Califf, CBER director Peter Marks, and Childrens Hospital of Philadelphia vaccine expert Paul Offit debate in the New England ...
The CDER Office of Generic Drugs annual report says it approved 914 new ANDAs in 2022 and took many other steps under the GDUFA 3 reauthorization.
FDA publishes the International Council on Harmonization Q13 guidance on continuous manufacturing of drug substances and products.
FDA outlines new potential GMP issues under policy consideration in a discussion paper entitled Artificial Intelligence (AI) in Drug Manufacturing.
