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Animal Drug Sponsor Name Changed

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a sponsor name change from North American Nutrition...

Comments Extended on PDUFA Reauthorization Meeting

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Federal Register Notice: FDA reopens the comment period on a public meeting soliciting input on reauthorization of PDUFA.

FDA Approves Egrifta for Lipodystrophy in HIV Patients

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FDA announces its approval of Montreal-based Theratechnologies tesamorelin, Egrifta, to treat lipodystrophy in HIV patients.

Merck Wins Court Decision to Block Teva's Generic Temodar

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Merck wins a federal appellate court decision blocking a Teva ANDA for a generic copy of its brain tumor drug Temodar (temozolomid...

Vitek Cards Recalled

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FDA says bioMrieux is recalling specific Vitek 2 negative susceptibility cards that are reporting incorrect results.

Amphetamine Sulfate Not Withdrawn for S&E

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Federal Register Notice: FDA determines that amphetamine sulfate 5 and 10 mg tablets was not withdrawn for reasons of safety or ef...

Special Control Guidance Available for Tissue Adhesive

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Federal Register Notice: FDA releases a special controls guidance on tissue adhesive with adjunct wound closure device intended fo...

FDA, Industry Scrap 'Info Sharing' in PDUFA Reauthorization

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FDA and drug industry representatives agree to remove a proposed information sharing phase as part of an alternative review model ...

GAO Report Critical of FDA Heparin Probe

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A new GAO report finds that FDA did not sanction some Chinese firms that refused to allow agency investigators access to perform a...

Hamburg Urges Caution in FDA Cuts

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FDA commissioner Margaret Hamburg says Republican House members should think carefully about the impact before cutting FDA funding...