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Obama Signs Order to Curb Drug Shortages

[ Price : $8.95]

President Obama signs an Executive Order directing FDA to take further steps to help further prevent and reduce prescription drug ...

FDA OKS Roche PMA for Hepatitis B Assay

[ Price : $8.95]

FDA grants Roche PMA approval for its Anti-HBc IgM assay for the in-vitro qualitative determination of IgM antibodies to hepatitis...

Medtronic Assurant Cobalt Iliac Stent Approved

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FDA approves a Medtronic PMA for the Assurant Cobalt Iliac Balloon-Expandable Stent System.

FDA OKs Gen-Probe Human Papillomavirus Assay

[ Price : $8.95]

FDA approves a Gen-Probe PMA for its Aptima HPV assay, an amplified nucleic acid test that detects high-risk strains of human papi...

J&J Files sNDA for Nucynta ER

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Johnson & Johnson Pharmaceutical Research & Development files a supplemental for Nucynta ER (tapentadol) seeking approval for mana...

FDA Panel Votes Down Medtronic Ablation Device

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An FDA advisory panel rejects a Medtronic PMA for its Phased RF Ablation System.

Dynavax Plans Early 2012 Hep B Vaccine BLA

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Dynavax Technologies says FDA has concurred with its plans to file a BLA early in 2012 on its Heplisav hepatitis B vaccine for per...

FDA OKs Medtronic IDE for ASPIRE Study

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FDA approves a Medtronic IDE to conduct a pivotal in-home clinical trial for the ASPIRE study involving the MiniMed Paradigm Syste...

FDA Clears Spinal USA Devices for Degenerative Disc Disease

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FDA grants 510(k) clearance to Spinal USA for Vault Stand Alone ALIF System for intervertebral body fusion of the spine in patient...

CVM Publishes Animal Antibiotic Sales Data for 2010

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CVM publishes its second annual report summarizing sales and distribution of antimicrobial drug products approved for use in food-...