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.
Clinical sites facing an inspection at the request of the Committee for Medicinal Products for Human Use must sign a letter consenting to the audit and promising to provide all relevant documents, a European Medicines Agency guideline on GCP inspection procedures says. Read More
Clinical research staff working on corrective and preventive action reports should think seriously about the root causes of good clinical practice violations identified at their sites and how to prevent those errors from recurring. Read More
Multiple lapses in informed consent and institutional review board procedures landed an FDA warning letter for clinical trial sponsor Rogerio Lobo, a physician in the Department of Obstetrics and Gynecology at Columbia University Medical Center in New York City. Read More
A Georgia clinical investigator was warned by the FDA for failing to properly randomize and dose patients participating in a GlaxoSmithKline study evaluating albiglutide in patients with type 2 diabetes. Read More
Investigators participating in clinical trials in India must limit their work to no more than three trials at any given time. That’s one of mandates laid out in 14 finalized regulations issued July 3 by the Central Drugs Standard Control Organization. Read More
The FDA is reaching out to sponsors of trials of therapies for neglected tropical diseases with new final guidance that encourages them to seek accelerated approval pathways, such as breakthrough therapy designation and qualified infectious disease product status. Read More
A trade group of leading Indian drug companies is pushing the government to settle a prolonged lawsuit over clinical trial deaths; a move that two industry consulting groups are hopeful will revive sluggish clinical trial activity in the country. Read More