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Death Misclassifications in MAUDE Database

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Researchers say they found substantial misclassification of patient deaths in the FDA MAUDE medical device database.

FDA Working with CBP to Identify Illicit Vaping Products

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FDA acting commissioner Ned Sharpless says the agency is working with Customs and Border Protection to identify potentially illici...

Medtronic Breakthrough with Aortic Aneurysm Stent

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FDA grants Medtronic a breakthrough device designation for its Valiant TAAA Stent Graft System for repairing thoracoabdominal aort...

Octapharmas Wilate Expanded Use in Adults/Adolescents

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FDA approves Octapharmas Wilate (von Willebrand factor/coagulation factor VIII complex) for treating adults and adolescents with h...

FDA Denies Olmesartan Withdrawal Petition

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FDA denies a Public Citizen petition seeking removal of products containing olmesartan medoxomil from the market for safety reason...

FDA Hits Troubled Aurobindo with Form-483

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FDA issues Aurobindo a Form-483 after an inspection last month at the firms Unit 7 manufacturing facility in Telangana, India.

Prices Increases Not Justified for 7 Drugs: ICER

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The Institute for Clinical and Economic Review identifies nine drugs whose 2017-2018 price increases were not supported by evidenc...

New Info Collection on FDA Fellowship Programs

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Federal Register notice: FDA submits to OMB a new information collection conflict of interest information for non-employee fellows...

6 FDA Software Exemption Guidances Analyzed

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Akin Gump attorneys highlight provisions in a package of six guidances issued by FDA to clarify its position on software exemption...

FDA Seeks Consumer Reps for Committees

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Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting and nonvoting consumer r...