Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest...more
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular - Five top executives at a major drug maker have been convicted of criminal racketeering for their...more
Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more
The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug...more
In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more