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FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile dr...[ Price : $8.95]
FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at ...[ Price : $8.95]
A Ropes & Gray legal update examines FDA initiatives to shorten drug development timelines and reduce regulatory burdens for spons...[ Price : $8.95]
Four stakeholders express varying opinions on the future direction and existence of the FDA national priority drug voucher program...[ Price : $8.95]
FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unapproved ophthalmic devices.[ Price : $8.95]
FDA temporarily suspends its controversial practice of publicly releasing Complete Response Letters for rejected drug applications...[ Price : $8.95]
FDA approves Johnson & Johnsons Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed fie...[ Price : $8.95]
Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical devic...