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Ocaliva Confirmatory Trial Fails: FDA

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FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocali...

GSK Nixes Herpes Simplex Virus Vaccine

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GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recen...

Hinge Health Wireless Pain Device Cleared

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FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

CDER Quantitative Medicine CoE Explained

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CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and reg...

CGMP Violations at Zydus Lifesciences Facility

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FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Multiple Optikem International Violations Cited

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FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthal...

Changes Sought in FDA Misinformation Guidance

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Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation abou...

FDA Clears Sonic Incytes Velacur Device

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FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Priority Voucher Used on Incytes Opzelura

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Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority rev...

FDA Mulls More Post-Inspection Feedback: Cavazzoni

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CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to lea...