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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]
Attorney James Beck reviews three court decisions based on lesser-known preemption arguments.[ Price : $8.95]
FDAs Denver District Office warns WalkMed Infusion about Quality System and other violations in its manufacturing of infusion pump...[ Price : $8.95]
FDA warns Nvision Laser Eye Centers about objectionable conditions in its conduct of research on an investigational new drug.