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FDA to Accept Applications for World Animal Health Agreement

[ Price : $8.95]

Federal Register Notice: FDA intends to accept an application for a cooperative agreement to the World Organization for Animal Hea...

Panel to Discuss NSAID Complications

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/4 to discuss evaluation of gastrointestinal c...

FDA Amends Notice on Panel Meeting Discussing Melanoma Detector

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Federal Register Notice: FDA amends the notice of an 11/18 meeting of the General and Plastic Surgery Devices Panel to change the ...

Gen-Probe Seeks Assay Clearance for Trichomonas Assay

[ Price : $8.95]

Gen-Probe submits a 510(k) for the Aptima Trichomonas Vaginalis assay and its use on the company's Tigris system.

Industry, Advocates Disagree on 510(k) Changes

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Two industry associations voice caution over some of FDAs recommendations for changing the 510(k) process while a citizen advocacy...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Absolute Packaging, Actelion Pharma, Amigo Mobility, BCIW, Capricorn Pharma, Fre...

Quality System Violations Found at Fresenius Facility

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FDAs New England District Office warns Fresenius over Quality System problems at its Waltham, MA, manufacturing facility for kidne...

Jazz Pharma Says FDA Received ANDA for Xyrem

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Jazz Pharmaceuticals says FDA has indicated that an ANDA has been submitted for a generic version of its narcolepsy drug Xyrem.

Info on Export Certificates Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on export of FDA-regulated products and export certifica...

Comments Sought on IVD Device Labels

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Federal Register Notice: FDA seeks comments on the reporting requirements for a collection of information on educational outreach ...