FDA Clarifies Guidance on Export Certificate Denials
The FDA released final guidance for devicemakers laying out the information it provides when it denies export certificate requests and the steps firms should take to appeal rejections. Read More
Health Canada Announces New Medical Device Directorate
Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Product... Read More
Devices News
Australian Court Finds J&J Liable for Mesh Injuries
The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Read More
GSK Accuses Boehringer Ingelheim of Lying About Its COPD Inhalers
GlaxoSmithKline (GSK) hit Boehringer Ingelheim with a lawsuit in a Pennsylvania federal court accusing it of false advertising over its dry powder inhalers Ellipta and Diskus for chronic obstructive pulmonary disease (COPD). Read More
FDA Issues Guidance on Transdermal and Topical Drug Delivery Systems
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance released Wednesday. Read More
Petition to FDA Questions Trial of Naltrexone Implant in Prisoners
BioCorRX’s use of a naltrexone implant for addiction treatment in state prisoners and the homeless was brought into ethical question by a consumer advocacy group in a citizen petition urging the FDA to launch an investigation. Read More
