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 federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness. Read More
Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management. Read More
Drugmakers must do more to ensure access to treatments for antimicrobial-resistant superbugs, but GlaxoSmithKline and Johnson & Johnson are doing more than other organizations on 16 metrics of progress, according to the Access to Medicines Foundation, a Netherlands-based non-profit. Read More
The European Medicines Agency adopted the International Council for Harmonization E7 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More
Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday. Read More