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Orphan Status for MediciNova Glioblastoma Drug

[ Price : $8.95]

FDA grants MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide fo...

FDA Funding to be Covered by Continuing Resolution

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Congress fails to secure passage of an FDA spending bill last week and it is looking very likely that the agencys funding will be ...

De Novo Clearance of Bose Hearing Aid

[ Price : $8.95]

FDA allows the de novo marketing of Bose Corp.s Bose Hearing Aid, the first hearing aid that enables users to fit, program and con...

Zeiss PMA Approved for Astigmatism Patients

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FDA approves a Zeiss PMA for ReLEx Smile to expand myopia treatment to patients with astigmatism.

Docket No. Corrected on Dietary Supplement Notice

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Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled Poli...

Info Collection Extension Sought for User Fee Forms

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Federal Register notice: FDA submits to OMB an information collection extension for Electronic User Fee Payment Request Forms For...

FDA Inspection Cites McKesson on Product Tracing

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A June FDA inspection of drug supplier McKesson results in a three-item Form 483 citing deficiencies with product tracing requirem...

Applied BioCode Gastro Pathogen Panel Cleared

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FDA clears an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode ...

Grant Implanted Device Exception: WLF

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Washington Legal Foundation asks the Utah Supreme Court to recognize that implanted medical devices are unavoidably unsafe.

Device Coordinated Voluntary Disclosures Good: Analysis

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The Medical Device Innovation Consortium lists the many benefits arising from adoption of coordinated voluntary disclosure policie...