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Watson Recalls 2 Lots of Hydrocodone/Acetaminophen

[ Price : $8.95]

Watson Laboratories recalls two lots of hydrocodone bitartrate and acetaminopen tablets, USP 10 mg/500 mg due to a possibility tha...

Astex Pharma Ditches Amuvatinib for Lung Cancer

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Astex Pharmaceuticals discontinues developing amuvatinib (MP-470), a multi-targeted tyrosine kinase inhibitor being evaluated for ...

Clinical Hold Lifted on Cinryze HAE Study

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FDA tells ViroPharma and Halozyme Therapeutics to amend their study protocol to resume clinical studies involving a subcutaneous a...

ANDA Filed for a Generic Copy of Pfizers Oxecta

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An unnamed generic drug company files a Paragraph 4 ANDA seeking approval to market a copy of Pfizers Oxecta (oxycodone HCl) table...

FDA OKs Mylans Valsartan Hydrochlorothiazide

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FDA grants final approval to Mylan Pharmaceuticals for its ANDA for valsartan and hydrochlorothiazide tablets USP for treating hyp...

FDA Clears Smiths Medical Safety System for Spinal/Epidural Meds

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FDA clears a Smiths Medical 510(k) application for the Portex CorrectInject Safety System for administering neuraxial medication.

OGD Outlines Bioequivalence Inspection Requirements in Draft Policy

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CDERs Office of Generic Drugs releases a draft policy outlining when the Centers Good Laboratory Practice/Bioequivalence Branch sh...

Shuren Sees Improving Numbers with CDRH Review Performance

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CDRH director Jeff Shuren says medical device review performance has been showing encouraging improvement since he took over the h...

FDA Cancer Czar Pazdur Given Leadership Award

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Friends of Cancer Research recognizes CDER Office of Hematology and Oncology Products director Richard Pazdur with its Cancer Lead...

Bill to Authorize GDUFA Fee Collection

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Attorney Kurt Karst says Congress is likely to consider legislation to authorize FDA to collect some GDUFA fees without an appropr...