[ Price : $8.95]
FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatm...[ Price : $8.95]
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in B...[ Price : $8.95]
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year we...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing faci...[ Price : $8.95]
NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and i...[ Price : $8.95]
A BioProcess International column says drug companies should design a controlled evidence ecosystem that can demonstrate to FDA in...[ Price : $8.95]
FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of...[ Price : $8.95]
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot ped...