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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cagenix and Laura Teasley.

Perrigo Drug Preemption Case Goes Back to Appeals Court

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The Supreme Court tells an appeals court to reconsider its ruling that Perrigo could comply with both state and federal laws speci...

FDA Corrects Notice on Cigarette Package Warnings

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the guidance on required warnings f...

FDA OKs Gen-Probe Human Papillomavirus Assay

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

CDRH Report Examines Barriers to Device Quality

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A new CDRH report says greater visibility on the agency's expectations of device quality and properly aligning its regulatory appr...

Vytorin Reduces CV Events in Kidney Disease Patients: FDA

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FDA says clinical data suggest that Merck/Schering Ploughs Vytorin (ezetimibe and simvastatin) is effective in reducing the risk o...

Obama Signs Order to Curb Drug Shortages

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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

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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.

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...