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 should make unredacted results of clinical trial site inspections more readily available to the public and to readers and editors of scientific journals, to ensure transparency about tainted studies and potentially bogus drugs, an article in the February JAMA Internal Medicine says. Read More
Biopharmaceutical companies can now pool and search clinical investigators’ information in a central, cloud-based database, thanks to an expanded investigator registry being developed by TransCelerate BioPharma and DrugDev. Read More
The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More