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 FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More
Novartis is facing fresh scrutiny after a Swiss newspaper revealed on Sunday that an unnamed executive at the drugmaker sold nearly $1 million in company stock just weeks before news broke of the data manipulation surrounding Zolgensma, its $2 million spinal muscular atrophy treatment. Read More
Syneos Health offered some suggestions for the FDA’s draft guidance for drugmakers on assessing the risks and benefits of opioids, urging the agency to highlight prior opioid exposure, guidance on tapering use and proper disposal. Read More