The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.”
Three former Genentech employees were indicted by a federal grand jury for allegedly stealing trade secrets from the San Francisco-based Roche subsidiary, which is pursuing litigation of its own against the ex-staffers. Read More
The latest opioid report from the office of Sen. Claire McCaskill (D-Mo.) delves into Insys Therapeutics’ sales policies for Subsys and concludes that the drugmaker used unethical methods to increase sales of its fentanyl product. Read More
“The opioid crisis these pills have fueled is a failure of policy and oversight by the government and a failure … on the part of many pharmaceutical companies and distributors,” McCaskill said. Read More