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Roche Ventana ALK Assay Approved by FDA

[ Price : $8.95]

FDA approves a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase-pos...

Objectionable Conditions Found at Dentists Clinical Site

[ Price : $8.95]

FDA warns California dentist William Domb about violations in his conduct of a clinical study using ozone generators.

Potential Pay-for-Delay Settlements Down: Report

[ Price : $8.95]

A Federal Trade Commission report says that the number of potential pay-for-delay patent dispute settlements in FY 2015 was signif...

CGMP Violations at Guangdong Zhanjiang Jimin

[ Price : $8.95]

FDA warns Chinas Guangdong Zhanjiang Jimin Pharmaceutical Co. about CGMP and other violations in its production of finished pharma...

False Claims Act Off-Label Promotion Case Fails

[ Price : $8.95]

Sixth Circuit Appeals Court decision upholds dismissal of a False Claims Act whistleblower case against Bristol-Myers Squibb based...

Class 2 for Health Risk Assessment Systems

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Federal Register notice: FDA classifies genetic health risk assessment systems into Class 2 (special controls).

Guide on Recurrent Herpes Labialis Drug Development

[ Price : $8.95]

FDA posts a guidance on Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention that discusses the overall develo...

FDA Reclassifies Sharps Needle Destructors Into Class 2

[ Price : $8.95]

Federal Register proposed order: FDA proposes to reclassify the needle destruction device, renaming the device to sharps needle de...

Harris Probing Alkermes Vivitrol Sales

[ Price : $8.95]

Sen. Kamela Harris says she is investigating efforts by Alkermes to artificially boost sales of its Vivitrol opioid addiction trea...

Vitamin D Mass Spectrometry Test Put Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the total 25-hydroxyvitamin D mass spectrometry test system into Class 2 (special controls...