An updated CBER guidance agenda for 2020 lists 29 planned guidances in four categories.
FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clar...
Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communications.
Axios/Ipsos poll respondents say they have little faith in FDA or the drug industry to be looking out for the publics interests.
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 ...