Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
New York’s attorney general is suing Insys for deceptive marketing of the spray form of one of its fentanyl products, a move the state says is part of a multi-pronged strategy to address the addiction crisis. Read More
The Seventh Circuit Court of Appeals in Chicago declined to revive several lawsuits against Pfizer over its testosterone drug Depo-T that had previously been among thousands of complaints in multidistrict litigation against testosterone drug manufacturers. Read More
Five health systems representing hundreds of U.S. hospitals plan to establish their own non-profit generic drug company to address drug shortages and bring competition to the generic drug market. Read More