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Study Questions Value of FDA Early Safety Alerts

[ Price : $8.95]

A study in the latest issue of Archives of Internal Medicine questions the value of quarterly MedWatch postings of new drug safety...

IMS Recommends FDA Early Warning System for Shortages

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A new report from IMS Institute for Healthcare Informatics recommends that FDA or the healthcare industry establish an early warni...

Comments Sought on Device Reclassification Petitions

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Federal Register Notice: FDA seeks comments on information collection requirements for reclassification petitions for medical devi...

Panel to Discuss NDA for Preterm Birth

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Federal Register Notice: FDAs Advisory Committee for Reproductive Health Drugs will meet 1/20/12 to discuss Columbia Labs NDA for ...

Genzyme NDA Planned for Multiple Sclerosis Therapy

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Genzyme says it will submit an NDA during the first quarter of 2012 for its multiple sclerosis therapy Lemtrada following favorabl...

FDA Panel Documents Support Prevnar 13 in Older Adults

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FDA review documents released before an advisory committee meeting appear to support expanded use of Wyeths Prevnar 13 in adults a...

Hamburg on Streamlining Drug Trial, Postmarket Data Collection

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FDA commissioner Margaret Hamburg telsl cancer researcher FDA is finalizing a guidance on streamlining data collection in late sta...

FDA Accepts NeurogesX sNDA for HIV Neuropathic Pain

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FDA accepts a supplemental NDA from NeurogesX, Inc. for a 30-minute application of its Qutenza 8% for managing neuropathic pain as...

Watson ANDA for Generic Exelon

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Watson Labs files an ANDA for a generic equivalent of Novartis Exelon patch used for treating mild to moderate dementia associated...

FDA OKs Watson Kadian Generic

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FDA approves a Watson Pharmaceuticals ANDA for morphine sulfate extended-release capsules, a generic of Actavis Kadian.