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FDA Concerned Over Factive-related Skin Rashes

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FDA reviewers say they are concerned about skin rashes associated with Oscients antibiotic Factive, which may deter approval of an...

FDA Guide on Drug Interaction Studies

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A new FDA draft guidance discusses how to conduct drug interaction studies on investigational drugs.

Lawmakers Seek Probe on FDAs Use of Non-inferiority Trials

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Five House and Senate lawmakers ask GAO to investigate FDAs acceptance of data from non-inferiority studies, citing concerns over ...

FDA Fines Red Cross $4.2 Million Under Consent Decree

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FDA orders American Red Cross to pay a further $4.2 million fine for failing to comply with its 2003 consent decree related to blo...

FDA Panel Votes Down White Paper on Dental Amalgam

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A joint advisory committee meeting says no conclusion could be drawn from a draft FDA white paper on potential adverse risks from ...

Genentech Signals Delay in Avastin Expanded Use

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Genentech says a major delay has occurred in expanding the indication for Avastin (to treat metastatic breast cancer in combinatio...

FDA OKs Ranbaxys Generic Imodium

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FDA approves a Ranbaxy Laboratory ANDA for a generic version of McNeils OTC Imodium Advanced Caplets.

Cortex Responds to FDA Clinical Hold

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Cortex Pharmaceuticals submits a complete response to an FDA clinical hold on its lead Ampakine compound for aging-related disorde...

Committee Recommends Abraxane Trial

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FDAs Oncologic Drugs Advisory Committee recommends a clinical trial for Abraxis BioSciences Abraxane for injectable suspension as ...

FDA Seeks PMAP Pilot Participants

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FDA and Health Canada want quality system auditing organizations to consider participating in a pilot multi-purpose audit program.