A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for

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

What is federal preemption? It’s an easier concept to grasp than you might think.

Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then went to ask your dad if you could go to the party, and he

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

Janice L. Weiner
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Room 6304
Silver Spring, MD 20993-0002

Dear Ms. Weiner,

We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes

We are pleased with a recent order issued by a Federal District Judge in Illinois, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is

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