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Quality System Violations in Wearable Therapy Production

[ Price : $8.95]

FDAs Detroit District Office warns Axiobionics about Quality System and other violations in its manufacturing of electrical stimul...

FDA Says Oregon IRB Failed to Protect Human Subjects

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FDA warns the Salem, Oregon, Hospital IRB about violations of the law and regulations that protect human research subjects.

FDA Uses Regulatory Science to Deny ANDA Petition

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Citing regulatory science advancements, FDA denies a Valeant Pharmaceuticals citizen petition asking the agency to not approve any...

FDA Drug Safety Alert on Jazz Xyrem

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An FDA drug safety alert reminds healthcare professionals and patients that Jazz Pharmaceuticals Xyrem should not be used in combi...

FDA Clears Quidel C. Difficile Assay

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FDA clears a Quidel Corp. 510(k) for its non-instrumented molecular diagnostic test, the AmpliVue C. difficile Assay.

Comments Sought on HDE Applications

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Federal Register Notice: FDA seeks comments on information to accompany humanitarian device exemption applications.

Guide on RFID Studies is Extended

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Federal Register Notice: FDA extends the expiration date on a compliance policy guide on radiofrequency identification feasibility...

Guidance on Enrichment Strategies in Trials for NDAs, BLAs

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Federal Register Notice: FDA releases a draft guidance, Enrichment Strategies for Clinical Trials to Support Approval of Human Dru...

FDA Releases Product-Specific BE Guidance

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Federal Register Notice: FDA releases additional product-specific guidance on the design of bioquivalence studies to support ANDAs...

Antares Files NDA for Self-Injectable Methotrexate

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Antares Pharma submits an NDA for Otrexup, a combination product for delivering methotrexate using Medi-Jet technology.