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Guide on Priority Zoonotic Animal Drugs

[ Price : $8.95]

FDA posts a draft guidance entitled Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.

Moderna Inspection Cites GMP Issues: Report

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FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a R...

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Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible ...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

Draft Guide on Dry Eye Drugs

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FDA posts a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsor...