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FDA Rejects Nicox NDA for Conjunctivitis Drug

[ Price : $8.95]

FDA sends Nicox a complete response letter on its NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching...

FDA Guide on Glucose Monitoring Systems

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FDA releases a guidance on Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use that describes studies and cri...

FDA Approves St. Jude Deep Brain Stimulator

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FDA approves a St. Jude Medical PMA for the Infinity Deep Brain Stimulation system and its DBS directional leads.

Public Meeting on Device User Fees Reauthorization

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Federal Register Notice: FDA announces an 11/2 public meeting on Medical Device User Fee Amendments (MDUFA) that will discuss prop...

FDA Posts Guidance on OTC Glucose Systems

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FDA posts a guidance on Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use that describes studies and criteria th...

FDA Accepts Coherus Application for Neulasta Biosimilar

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FDA accepts a Coherus BioSciences BLA for CHS-1701, a pegfilgrastim (Amgens Neulasta) biosimilar candidate.

FDA Clears Adapta Medical Urinary Catheter

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FDA clears an Adapta Medical 510(k) for the PerfIC Cath intermittent touchless urinary catheter.

List Revised on Drug Products That Can't Be Compounded

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Federal Register Final Rule: FDA amends its regulations to revise the list of drug products that have been withdrawn or removed fr...

FDA Clears Fresenius Aurora Xi Plasma System

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FDA clears a Fresenius Kabi 510(k) for the Aurora Xi Plasmapheresis System for use in collecting plasma.

Flamel Gains Special Protocol for Narcolepsy Drug

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Flamel Technologies reaches agreement with FDA for a special protocol assessment for the design and planned analysis of a Phase 3 ...