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FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.[ Price : $8.95]
FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with pr...[ Price : $8.95]
CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical d...[ Price : $8.95]
FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, ...[ Price : $8.95]
Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopre...[ Price : $8.95]
FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.[ Price : $8.95]
Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experienc...[ Price : $8.95]
FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.