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FDA Rule on Charging Patients for Investigational Drugs

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Federal Register Proposed rule: FDA proposes to amend its regulations by clarifying the circumstances in which charging for an inv...

People Want More Safety, Side Effects Info

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Respondents to a Pharmaceutical Safety Institute survey say they want more information on drug side effects and safety issues.

Baxter Conditional Approval on Colleague Pump Correction

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FDA gives Baxter Healthcare conditional approval for a plan to correct its troubled Colleague drug infusion pump.

New Info Could Increase Doc DTC Support

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Physicians participating in Sermos online community say they could support DTC ads that better explained relative and individual r...

Merck Plans Vaccine Production Boost in New Facility

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Merck intends to expand a vaccine manufacturing production facility in Durham, NC to support its growing vaccine business.

Epix to Appeal to Galson Over Vasovist

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Epix Pharmaceuticals says it will appeal a finding last August that its blood-pool imaging agent Vasovist had not been shown safe ...

Celgene Challenges Barr ANDA for Thalidomide

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Celgene Corp. says it will file a patent infringement suit against Barr Pharmaceuticals over its ANDA for a generic copy of Thalom...

FDA OKs Blood Screening Test for Chagas Disease

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FDA approves Orthos Ortho T. cruzi ELISA Test System the first test used for screening blood donors to detect a blood-borne paras...

Committees Asked to Consider Ketek MedGuide

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FDA asks two advisory committees whether additional provider education and a MedGuide are the best ways to deal with adverse event...

FDA Wants More Info on Pozens Trexima

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Pozen officials say they will submit a revised response to FDAs approvable letter on Trexima by years end.