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FDA warns Nvision Laser Eye Centers about objectionable conditions in its conduct of research on an investigational new drug.[ Price : $8.95]
FDA clears a Caputron Medical 510(k) for its mindGear headset for treating depression, insomnia and anxiety.[ Price : $8.95]
Two Epstein Becker Green attorneys write that a False Claims Act case involving a manufacturing firm making allegedly false certif...[ Price : $8.95]
The FDA Group says that independent Good Clinical Practice audits help ensure that clinical trial subjects rights are respected an...[ Price : $8.95]
Bestmed recalls its Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co. due to a manufacturing problem ...[ Price : $8.95]
A drug industry proposal at a PDUFA negotiation meeting seeks FDA processes to facilitate appropriate use of innovative clinical t...[ Price : $8.95]
FDA sends Repros Therapeutics a complete response letter on an NDA for enclomiphene for treating secondary hypogonadism in overwei...[ Price : $8.95]
FDA sends Bristol-Myers Squibb a complete response letter, declining to approve a supplemental BLA for Opdivo (nivolumab) as a sin...