FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate deh...
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in Bangalore.
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year were indicated for use...
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ...
NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and inspectors are genera...
A BioProcess International column says drug companies should design a controlled evidence ecosystem that can demonstrate to FDA inspectors that data t...
FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of its investigational...
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot pedal accessories.
