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AstraZeneca Seeks Nexium Approval in Newborns

[ Price : $8.95]

AstraZeneca submits a supplemental NDA for Nexium, seeking approval for short-term (up to 6 weeks) treatment of gastroesophageal r...

Guidance on Cardiovascular Risk in Antidiabetic Therapies

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Federal Register Notice: FDA releases a guidance on evaluating cardiovascular risk in new antidiabetic therapies.

Comments Sought on Emergency Shortages System

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Federal Register Notice: FDA seeks comments on the Emergency Shortages Data Collection System.

Comments Sought on Device Recall Authority

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Federal Register Notice: FDA seeks comments on FDAs medical device recall authority.

11 Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that 11 drug products were not withdrawn from sale for reasons of safety or effectiveness.

ViroPharma Sues for Vancocin FDA Record

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ViroPharma says FDA and HHS have not responded to its requests for the administrative record on Vancocin bioequivalence and it is ...

Advocacy Groups: FDA Needs Strong Scientific Chief

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Industry-connected health and disease advocacy organizations call for an FDA commissioner who is science-driven and can bring vari...

Orphan Products Has Funding Opportunity

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Federal Register Notice: FDAs Office of Orphan Product Development provides notice of a funding opportunity announcement for feder...

FDA Clears IMRIS Neuro Imaging System

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FDA clears an IMRIS Inc. 510(k) for the 3 Tesla IMRISneuro imaging system.

Larger Personalized Medicine Trials Needed

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Oncologic Drug Advisory Committee panelists say companies may need to do larger clinical trials to demonstrate that they can use g...