The European Medicines Agency (EMEA) has published a draft guideline describing scientific principles and methodology for conducting environmental risk assessments (ERAs) of gene therapy medicinal products that contain genetically modified organisms, or GMOs.
Sponsors wishing to test high-risk new drugs for the first time on human subjects are advised to undertake additional preliminary studies in some circumstances, under a new draft guideline from the European Medicines Agency (EMEA).
Individual adverse events in clinical trials are not necessarily the same thing as unanticipated problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA.
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) under its new chairman, Samuel Tilden, has recommended ethics training for investigators, IRB members and others, and has proposed a definition of “minimal risk” clinical trials.
Sponsors wishing to test new high-risk drugs for the first time in human subjects are advised to conduct additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA).
Results from a recent open-label study showed that Pfizer’s antibiotic Zyvox increased the risk of death in patients with Gram-negative, catheter-related infections, according to an FDA MedWatch report issued March 16.