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.
Synthetic opioids have overtaken prescription opioids as the leading cause of overdose deaths in the U.S., according to a report published by the Journal of the American Medical Association, which studied 2010-2016 mortality data. Read More
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee is requesting that sponsors of antiretrovirals submit, by May 8, supplementary safety information related to the risk of autoimmune hepatitis. Read More
A Louisiana federal judge managing the tide of lawsuits against the blood thinner Xarelto (rivaroxaban) ordered them to be prepared for trial in individual federal courts nationwide, with selection and discovery to take place in two waves of 600 cases each. Read More
The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. Read More