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Nominations Sought for Device Panels

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Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device pane...

FDA Mulls 510(k) Sterilization Master File

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FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medic...

Draft Guide on Inspecting for Particulates

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Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible ...

Manual Percutaneous Surgical Set is Class 2

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Federal Register notice: FDA classifies the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 ...

CDER Ramps Up Enforcement of ClinicalTrials.gov Compliance

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CDER Office of Compliance director Donald Ashley says the Center has ramped up its enforcement of ClinicalTrials.gov compliance, s...

Researchers Examine Modeling for Pediatric Dose Selection

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FDA researchers work with industry and clinicians to determine the best way to apply modeling information to improve pediatric dos...

Possible False Positive with Syphilis Test

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FDA alerts clinical laboratory staff and health care providers that false reactivity or a false positive test result is possible w...

FDA Modifies REMS for Mifepristone

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FDA modifies a Risk Evaluation and Mitigation Strategies program for mifepristone, a drug used in early abortion and miscarriage c...

Getinge/Datascope/Maquet Cardiosave Recall is Class 1

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FDA says the Getinge/Datascope/Maquet recall of Cardiosave intra-aortic balloon pumps is Class 1.

Administration Sidelining Vaccine Scientists: Ex-FDAers

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Two former FDA scientists say it is a mistake for FDA and CDC to bypass advisory committees when making Covid vaccine decisions.