GCP

EMA Finalizes Pediatric Investigation Plan Guideline

Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More

OHRP Offers Tips on Reporting Clinical Trial Incidents

Clinical trial staff should report serious or continuing noncompliance issues and unanticipated problems occurring at trial sites to HHS’ Office of Human Research Protections in no more than a month, says Kristina Borror, director of OHRP’s Division of Compliance Oversight. Read More