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Info Collection on Custom Device Exemption

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Annual Reporting for Custom Device Exemptio...

FDA Releases Drug Approval Compilation Since 1985

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FDA launches a new resource for external and agency researchers collecting historical information about FDAs drug approvals.

Device Panel to Review 5 Classifications

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Federal Register notice: FDA announces a 4/23-24 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Commi...

Guide on Drug eSubmissions Using cCTD Specs

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FDA posts a revised guidance on drug application submissions that use electronic Common Technical Document specifications.

Pilot Backs Blockchain for Drug Supply Security

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A drug supply chain security pilot program endorses blockchain technology to meet Drug Supply Chain and Security Act requirements ...

15 No Longer Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 15 ANDAs from multiple applicants after notifying the agency that they are no l...

Prometra II Pump Approved for Intrathecal Baclofen

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FDA approves a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen.

KinetiCor MRI Motion Correction Cleared

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FDA clears a KinetiCor 510(k) for the KinetiCor Motion Correction System and its use with Siemens Magnetom Skyra 3T MRI scanner.

FDA Issues Insulin Transition Final Rule

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FDA issues a final rule and other documents in advance of the 3/23 transition of biological products from Federal Food, Drug, and ...

FDA Ignoring Fines for Failing to Report Trials: Column

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Research into reporting of clinical trials shows that while FDA could have issued fines of more than $4 billion for companies that...