Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public...
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
A final rule published by the Centers for Medicare and Medicaid Services (CMS) requires drug manufactures, including contract manufacturing organizations (CMOs) and group purchasing organizations (GPOs) to report annual payments to physicians or investment interests...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
