Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”.

Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies

A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014).

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry.

To that end, Congress passed the Drug