FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center master files.
National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job of evaluating produc...
Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing significant reductions in...
A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and many have financial co...
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN.
U.S. House and Senate health committee leaders express concern about a new FDA review pilot program because it appears designed to enable corruption a...
FDA investigators cite Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-control deficiencies...
FDA issues an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump primary administration sets.
