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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 Closely Monitoring Predaxa Adverse Events

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FDA says it is keeping a close eye on fatal bleeding cases associated with Boehringer Ingelheims Pradaxa, indicated for preventing...

FDA Alumni Assn. Gives Media the Boot

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In what may be the latest example of FDAs dwindling transparency, the FDA Alumni Association forbids news media coverage of its me...

OMB OKs Info on Orphan Drug Form

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Federal Register Notice: The Office of Management and Budget approves a collection of information on orphan drugs and a common Eur...

Study Questions Value of FDA Early Safety Alerts

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