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.
House GOP lawmakers are concerned that the FDA has expanded rapidly under President Barack Obama’s administration and want the agency to justify the additional 8 percent budget increase the president has proposed for it in 2015. Read More
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
GlaxoSmithKline has withdrawn a marketing application for a cancer drug combination in Europe, saying it will wait for results from two ongoing Phase III trials before resubmitting the application. Read More
A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More