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FDA sends Nicox a complete response letter on its NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching...[ Price : $8.95]
FDA releases a guidance on Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use that describes studies and cri...[ Price : $8.95]
FDA approves a St. Jude Medical PMA for the Infinity Deep Brain Stimulation system and its DBS directional leads.[ Price : $8.95]
Federal Register Notice: FDA announces an 11/2 public meeting on Medical Device User Fee Amendments (MDUFA) that will discuss prop...[ Price : $8.95]
FDA posts a guidance on Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use that describes studies and criteria th...[ Price : $8.95]
FDA accepts a Coherus BioSciences BLA for CHS-1701, a pegfilgrastim (Amgens Neulasta) biosimilar candidate.[ Price : $8.95]
FDA clears an Adapta Medical 510(k) for the PerfIC Cath intermittent touchless urinary catheter.[ Price : $8.95]
Federal Register Final Rule: FDA amends its regulations to revise the list of drug products that have been withdrawn or removed fr...