FDA warns Schaumburg, IL-based Sunstar Americas about drug CGMP and medical device QS violations at its manufacturing facility.
FDA releases three case study summaries from the complex innovative trial design pilot program.
FDA issues the latest FDA-483 from an inspection at the troubled Catalent fill and finish contract manufacturing facility in Brussels, Belgium.
FDA warns South Koreas Cosmo Bio about CGMP violations in its production of a misbranded and unapproved over-the-counter acne drug.
FDA issues Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and...
FDA extends by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies betibeglogene autotemc...
FDA and the medical device industry are at a standstill in their negotiations on the next five-year iteration of the medical device user fee agreement...
FDA Review posts product approval summaries for the week ending 1/30/2022.