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Workshop on Pediatric Clinical Trial Endpoints

[ Price : $8.95]

Federal Register notice: FDA announces an 11/12 public workshop on patient perspectives in pediatric clinical trial endpoints for ...

Priority Voucher Awarded to Bavarian Nordic

[ Price : $8.95]

Federal Register notice: FDA announces that it has issued a material threat medical countermeasure priority review voucher to Bava...

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Clarus Wants FDA Testosterone-Ester Guidance

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Clarus asks FDA for written guidance on safety and efficacy standards needed for approval of an application for oral testosterone-...

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...