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.
A healthcare overhaul bill that would give innovator biologics 12 years of data protection and create two comparative-effectiveness research centers was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee. The Affordable Health Choices Act, which passed by a 13–10 vote, is the first congressional healthcare overhaul bill to advance out of committee. The bill would allow an innovator product only one period of data exclusivity to prevent innovators from making minor changes to a product to obtain another 12-year period of exclusivity. Drug Industry Daily