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Liver-Specific Contrast Agent Gets Orphan Drug

[ Price : $8.95]

FDA grants orphan drug status to CMC Contrast AB for its liver-specific contrast agent for diagnostic MRI for detecting liver lesi...

Comments Sought on Importers Entry Notice

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection in FDAs Importers Entry Notice.

Comments Extended on Asthma Drug Bioequivalence

[ Price : $8.95]

Federal Register Notice: FDA is reopening the comment period Draft Guidance for Industry on Bioequivalence Recommendations for Flu...

Comments Extended on Generic Drug User Fee Guidance

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a draft guidance on the generic drug user fee amendments of 2012.

Panel to Discuss REMS Communications

[ Price : $8.95]

Federal Register Notice: FDAs Risk Communications Advisory Committee will meet 12/17 to discuss new methods for communication risk...

FDA Seeks Sponsors for Study Data Pilot

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Federal Register Notice: CDER and CBER announce a pilot project to evaluate the Clinical Data Interchange Standard Consortium Subm...

FDA Clears Upgraded HammerLock Fixation System

[ Price : $8.95]

FDA clears a BioMedical Enterprises 510(k) for an upgrade to its HammerLock Nitinol Intramedullary Fixation System.

FDA Clear Elekta Treatment Planning System

[ Price : $8.95]

FDA clears an Elekta 510(k) for the Monaco 5, the latest version of its Monaco treatment planning system.

QRxPharma Resubmits Moxduo NDA

[ Price : $8.95]

harma resubmits its Moxduo NDA to confirm data validity sought by the agency.

Sigmapharm Wants Specific BE Studies for Saphris ANDAs

[ Price : $8.95]

Sigmapharm asks FDA to refuse to receive ANDAs for generic Saphris that dont contain a bioequivalence study conducted under terms ...