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AAM Comments on Controlled Correspondence

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The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workl...

Biosimilars Forum, PhRMA Support BsUFA 3

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The Biosimilars Forum and PhRMA say they support the third biosimilar user fee agreement negotiated with FDA.

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...

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Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug produ...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

2 Antisense Oligonucleotide Drug Guidances

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FDA issues draft guidances with clinical recommendations and chemistry, manufacturing, and controls recommendations for sponsors d...