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FDA Approves LIA Software for Non-Medtronic Leads

[ Price : $8.95]

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Federal Register Notice: FDA releases a draft guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Ampli...

A New FDA Wrinkle? Just Dont Approve Nasty Products

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Washington commentator Bob Steeves says FDA may be deliberately refusing to approve any new tobacco products, thereby choking off ...

FDA Raises Many Ampligen Concerns

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FDA tells the Arthritis Advisory Committee it has concerns about the efficacy and safety of Hemispherx Biopharmas Ampligen in trea...

Merck, GE to Collaborate on Alzheimers Candidate

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Merck and GE Healthcare collaborate on a clinical study and license and supply agreement to use GEs investigational PET imaging ag...

Comments Sought on Device Review Assessment

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Federal Register Notice: FDA seeks comments on the comprehensive assessment of the device submission review process.