FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves Expanded Indication for Erbitux

[ Price : $8.95]

FDA approves Bristol-Myers Squibbs Erbitux (cetuximab) for use with chemotherapy to treat patients with metastatic head and neck c...

FDA Clears Quidel Influenza A+B Immunoassay

[ Price : $8.95]

FDA clears a Quidel 510(k) for the Sofia analyzer and Sofia Influenza A+B Fluorescence Immunoassay.

Congress Should Overhaul FDA Review Process: Op-ed

[ Price : $8.95]

A Forbes op-ed says Congress should overhaul FDA's review processes when it takes up the user fee reauthorization early next year.

FDAs Gold Standard Seen as Yielding to a New Identity

[ Price : $8.95]

FDA Matters commentator Steven Grossman sees an identity crisis at FDA as it struggles to uphold its gold standard while advancing...

Guidance on Cancer Vaccines

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Clinical Considerations for Therapeutic Cancer Vaccines.

Comments Sought on Prescriber Education for Opioid Class

[ Price : $8.95]

Federal Register Notice: FDA releases a draft document for comments, Blueprint for Prescriber Education for the Long-Acting/Extend...

Workshop on Surgical Devices

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 12/2 on evidence development for surgical medical devices and procedures.

FDA Conditionally OKs Edwards Expanded Valve Study

[ Price : $8.95]

FDA conditionally approves an Edwards Lifesciences expanded study involving its next-generation Sapien XT transcatheter heart valv...

Yersinia Species IVDs into Class 2

[ Price : $8.95]

Federal Register Proposed rule: FDA proposes to classify in vitro diagnostic devices for Yersinia species into Class 2 with a guid...

Comment Period Extended on De Novo Classification Guidance

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period on a draft guidance on the de novo classification process.