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Objectionable Conditions at Nvision Eye Center

[ Price : $8.95]

FDA warns Nvision Laser Eye Centers about objectionable conditions in its conduct of research on an investigational new drug.

FDA Clears Caputron Medical Brain Stimulator

[ Price : $8.95]

FDA clears a Caputron Medical 510(k) for its mindGear headset for treating depression, insomnia and anxiety.

Bank False Claims Case Can Affect Healthcare Suits

[ Price : $8.95]

Two Epstein Becker Green attorneys write that a False Claims Act case involving a manufacturing firm making allegedly false certif...

GCP Audits Look at Research Quality

[ Price : $8.95]

The FDA Group says that independent Good Clinical Practice audits help ensure that clinical trial subjects rights are respected an...

Bestmed Recalls Faulty Digital Thermometers

[ Price : $8.95]

Bestmed recalls its Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co. due to a manufacturing problem ...

Innovative Trial Design Proposal Discussed at PDUFA Meeting

[ Price : $8.95]

A drug industry proposal at a PDUFA negotiation meeting seeks FDA processes to facilitate appropriate use of innovative clinical t...

Repros Gets Complete Response Letter for Enclomiphene

[ Price : $8.95]

FDA sends Repros Therapeutics a complete response letter on an NDA for enclomiphene for treating secondary hypogonadism in overwei...

Complete Response on BMS Opdivo sBLA

[ Price : $8.95]

FDA sends Bristol-Myers Squibb a complete response letter, declining to approve a supplemental BLA for Opdivo (nivolumab) as a sin...

FDA Clears Siemens Robotic X-ray System

[ Price : $8.95]

FDA clears a Siemens Healthcare 510(k) for the Multitom Rax (Robotic Advanced X-ray), a universal diagnostic imaging system intend...

Panel to Discuss NDA/sNDA for Major Depressive Disorder

[ Price : $8.95]

Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 2/3/16 to discuss cognitive dysfunction in ma...