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Data Reinforce Nirsevimab RSV Efficacy: Sanofi/AstraZeneca

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Sanofi and AstraZeneca say additional Phase 3 and Phase 2b trial data continue to demonstrate nirsevimab efficacy against respirat...

Surgical Mask Review Memo Posted

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FDA adds a surgical mask 510(k) review memo to its library of redacted memos for selected medical devices with a high volume of th...

FDA Debars Massouh Over Misbranded Drugs

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Federal Register notice: FDA denies a debarment hearing request from Marwan Massouh and issues an order debarring him for three y...

Gastrointestinal Drugs Committee Renewal

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Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years.

Veru Preparing EUA Application for 2nd Quarter

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Veru says it will submit a second-quarter application to FDA for an emergency use authorization for sabizabulin to treat some hosp...

Sun Pharma Gets 10-item FDA-483

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FDA issues Sun Pharmaceutical Industries a 10-item Form FDA-483 after conducting a 5/9-concluded inspection of its Halol facility ...

House Subcommittee Unanimously Votes Out User Fee Bill

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The House Energy and Commerce Committee unanimously votes (30 to 0) to advance a legislative package that would reauthorize FDA us...

FDA Extends Expiration Dating on Bivigam

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FDA approves an ADMA Biologics request to extend the expiration date from 24 to 36 months for Bivigam (immune globulin intravenous...

CBER Ups Likely 2022 Guidances

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CBER increases from 13 to 17 the number of guidances it expects to develop in 2022.

FDA Needs More Digital Power: Patel

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Former FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional congressional authorities to ...