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Info on Expedited Programs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on expedited drug and biologic programs fo...

FDA Approves LIA Software for Non-Medtronic Leads

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FDA approves Medtronic Lead Integrity Alert software for use with non-Medtronic defibrillator leads.

Activity Found in Genetic Pathway for Pediatric Tumors

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Researchers at Johns Hopkins find a known genetic pathway to be active in many difficult-to-treat pediatric brain tumors called lo...

Aeterna Zentaris Submits NDA for Growth Hormone Drug

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Aeterna Zentaris submits an NDA to FDA for macimorelin acetate to induce growth hormone release to evaluate adult growth hormone d...

FDA Funds Study on Generic Transplant Drug Equivalence

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FDA agrees to fund studies at the University of Cincinnati to evaluate the safety and efficacy of a generic immunosuppressive drug...

FDA Speakers Update Agency Cancer Efforts

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FDAers Richard Pazdur and Liz Mansfield update the Institute of Medicines National Cancer Policy Summit on some CDER and CDRH acti...

Guidance on Hearing Devices

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Federal Register Notice: FDA releases a draft guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Ampli...

FDA Approves Hologic Aptima HPV Assay

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FDA approves a Hologic PMA for the Aptima HPV 16 18/45 genotype assay for use on the companys fully automated Panther system.

FDA Clears TiO2Mesh for Hernia Repair

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FDA clears a BioCer Entwicklungs 510(k) for its TiO2Mesh hernia repair system for repairing soft tissue defects in the abdominal w...

510(k) Benefit-Risk Determinations Guidance Top Priority

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A new CDRH Web site places developing a draft guidance on Benefit-Risk Determinations in Premarket Notifications (510(k)s) as one ...