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From FDAs Dept. of Dirty Tricks: TMJ Implants Case

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FDA documents obtained under discovery appear to show an agency Department of Dirty Tricks operating over at least three years to ...

Info on CLIA Waivers Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on clinical laboratory improvement amendments to the Off...

Review Period Set for Ketek

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Federal Register Notice: FDA has determined the regulatory review period for Aventis Ketek is 2,206 days.

Approved PMA List Published

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Federal Register Notice: FDA releases a list of premarket approval applications that have been approved.

FDA to Hold Nanotechnology Public Meeting

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Federal Register Notice: FDA plans a public meeting 10/10 in Bethesda, MD on nanotechnology as it relates to FDA-regulated product...

FDA OKs Purina Cattle Feed

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Federal Register Final rule: FDA approves a Purina Mills supplemental NADA for using lasalocid to make medicated feed for pasture ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Hawkins and Smith Medical Critical Care.

FDA Plans Big Risk Communication Review

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FDA senior advisor on risk communications Nancy Ostrove says the agency is planning to undertake important new research soon on ho...

Drug Import Provision OKd

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House and Senate budget negotiators approve a proposal to allow U.S. residents to carry some prescription drugs back from Canada.

Alaris Infusion Pump Recall is Class 1

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FDA says Cardinal Healths 8/10 recall of Alaris SE infusion pumps is a Class 1 recall.