FDAs New England District Office warns Oxford Performance Materials about Quality System violations in its manufacturing of 3D-printed cranial and max...
FDAs Seattle District Office warns Vidco, Inc., about Quality System and Medical Device Reporting Regulation violations in its manufacturing of patien...
FDAs New Jersey District Office warns Vertical Pharmaceuticals about Postmarketing Adverse Drug Experience reporting violations.
FDA grants Sangamo Therapeutics a fast track designation for SB-525, a clinical stage complementary-DNA gene therapy candidate for hemophilia A.
FDA releases its latest batch of Warning Letters that includes Howard Phillips LLC., International Medsurg Connection, Oxford Performance Materials, V...
FDA approves a Pharmadax ANDA for a generic copy of Seroquel XR (quetiapine fumarate) extended release tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 ...
Attorney Matthew Curley looks at False Claims Act suits over speaker programs and other potential areas of liability for drug and medical device manuf...
Eleven Democratic senators call on the president not to hurt implementation of the 21st Century Cures Act through budget cuts and workforce reductions...