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Breakthrough Device Changes Needed: Research

[ Price : $8.95]

Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursem...

Draft Guide on Remote Interactive Evaluations

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Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresear...

Qiagen, Myriad Partner on Cancer Diagnostics

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Qiagen and Myriad Genetics announce a collaboration to develop cancer companion diagnostic tests.

Consolidated OPDP Untitled Letters Page

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CDERs Office of Prescription Drug Promotion launches a new Web page to display untitled letters issued for drug advertising and pr...

Add Device Identifier to Medicare Forms: Senators

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Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.

GSK Seeking Expanded RSV Vaccine Use

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After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (...

Info Collection on Public Health Projects

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Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federal...

CDER Made Erroneous Statements to A/C: Letter

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Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER off...

Remote Interactive Evaluation Guidance

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FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of so...

Medinol Gets OK on Latest Drug-Eluting Stent

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FDA approves Medinols EluNIR-PERL drug-eluting stent for treating coronary artery disease.