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Medtronic Pacing Lead Gets Expanded Labeling

[ Price : $8.95]

FDA approves expanded labeling on Medtronics SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing.

Real-World Evidence Program Announced

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Federal Register notice: FDA announces the Advancing Real-World Evidence (RWE) Program, which was agreed to under the recent user ...

Comments Extended on Animal Generic User Fees

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Federal Register notice: FDA extends the comment period associated with a 9/30 notice on the proposed recommendations for the reau...

Guide on GMPs for Animal Cell/Tissue Products

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Federal Register notice: FDA makes available a final guidance #253 entitled Current Good Manufacturing Practice for Animal Cells, ...

Multiple Clinical Trial Endpoints Guidance

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FDA publishes a guidance on accounting for multiple endpoints in the analysis of drug and biologic clinical trials.

Talaris Reports FREEDOM-1 Study Death

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Talaris says it has informed FDA about the death of a subject in the FREEDOM-1 trial of FCR001 in live donor kidney transplant rec...

ImClone Systems FDA-483

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FDA releases the form FDA-483 with two observations from an inspection at Branchburg, NJ-based ImClone Systems.

Dont Wait for SBOM Finalization: Fu

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Former CDRH cybersecurity acting director Kevin Fu says the best companies are already submitting software bills of materials with...

Hikma Injectables Hit With 3-item FDA-483

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A recent inspection at Hikma Injectables USA results in a three-item Form FDA-483.

Breakthrough Device Guidance Updates

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FDA publishes a draft guidance on proposed updates to an earlier breakthrough devices program guidance.