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Lessons Learned from Gene Therapies: CBER Official

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CBER Office of Tissues and Advanced Therapies director Wilson Bryan addresses the lessons learned from FDAs limited experience in ...

EUA Approved for AstraZenecas Evusheld

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FDA issues an emergency use authorization for AstraZenecas Evusheld monoclonal antibody Covid pre-exposure prevention for some adu...

Teligent Recalls 2 Topical Lidocaine Lots

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Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal test...

2 Influencers Call for Using More RWD in Trials

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Two MedHealth influencers say the health community must find ways to expand the use of real-world data in clinical trials.

CBER Cell/Gene Therapy Office Swamped: Director

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CBER Office of Tissues and Advanced Therapies director Wilson Bryan says the office is swamped with new product submissions to the...

Hahn Leading Harbinger Health Testing Startup

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Former FDA commissioner Stephen Hahn is named CEO of Harbinger Health.

Gilead Recalls 2 Veklury Lots

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Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of ...

FDAs Broadening Approval Authority Explained

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Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug produ...

510(k) Required for Powered Patient Transports: FDA

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Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the g...

FDA Updates Covid Test Info with Omicron

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FDA adds omicron updates to its Web page on viral mutations and their impact on Covid tests.