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Real-World Data Standards Guidance

[ Price : $8.95]

FDA publishes a draft guidance on data standards for applicable drug submissions using real-world data.

FDA Expanding Covid Work with Aetion

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FDA expands its Covid-19 regulatory science work with Aetion.

FDA OKs Luminopia One for Lazy Eye

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FDA gives de novo premarket approval to Luminopia One to use a virtual reality headset to treat amblyopia, or lazy eye, in childre...

Clinical Hold on AZ Blood Cancer Drug

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FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one...

Merck Recalls 1 Lot of Cubicin

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Merck recalls one lot of Cubicin (daptomycin for injection) 500mg for intravenous use due to a complaint being received about a pi...

Dupixent Approved as Asthma Add-on Maintenance

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FDA approves Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for certain patients ag...

FDA OKs Esteve Pharmas Pain NDA

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FDA approves an Esteve Pharmaceuticals NDA for Seglentis (celecoxib and tramadol hydrochloride) for treating acute pain in adults.

CDC Panel Backs Covid Booster Vaccines

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CDCs Advisory Committee for Immunization Practices votes to recommend accepting FDAs 10/20 amended emergency use authorizations fo...

FDA Denies Stryker Patient Transport Exemption

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FDA denies a Stryker Medical petition seeking a premarket notification exemption for some powered patient transport devices.

Bryant Ranch Recalls Mislabeled Methocarbamol

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Bryant Ranch Prepack recalls one lot of methocarbamol 500mg tablets due to a mislabeling error.