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Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites Heritage Pharmaceuticals and Life Support Development.

Positive Results in Gilead Zydelig Study

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Gilead says its Phase 3 study of Zydelig combined with bendamustine and rituximab for treating patients with relapsed chronic lymp...

FDA Orders Mfr. Pediatric Studies of Contrast Media

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FDA says it is requiring manufacturers of iodinated contrast media to study the potential for infants to develop underactive thyro...

Another CDRH Letter Challenges Marketing of Test for Consumers

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FDA continues its crackdown against laboratory-developed test makers, sending a letter to HarmonyX about its tests for antiplatele...

FDA Corrects Final Rule on Tobacco Product Marketing

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Federal Register Notice: FDA corrects certain reference numbers in the preamble to a 9/24 final rule on environmental assessments ...

Should FDA Move to European Model for Approving Devices/Drugs?

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An opinion piece by a former FDA official in the Charleston Gazette-Mail says the U.S. would be better served if it moved more tow...

CDER Reports Problems with Clozapine REMS Program

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CDER says it is receiving reports from healthcare professionals about ongoing difficulties with the Clozapine REMS Program, includ...

FDA Guidance on Acetaminophen Liver Warning Labeling

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FDA posts a guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Cou...

Draft Guidance on IVDs for Bacillus spp. Detection

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FDA releases a draft guidance on Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection.

FDA Asks for More Data on Clovis Lung Cancer Drug

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FDA requests additional efficacy clinical data as part of its review of an NDA for rociletinib (500mg and 625mg BID), indicated fo...