The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Post-approval research on existing medicines has improved patient outcomes and addressed unmet medical needs. In oncology, post-approval improvements to drugs reflect indications for additional ...

Any activity involving humans as participants in research must gain approval or exemption from the HSRB before the research may be undertaken. ... HSRB chair. If the chair agrees, a formal exemption ...

Faculty, postdoctoral fellows, graduate students, and staff may request approval for essential University-related international travel for research purposes. If your proposed travel meets the criteria ...

For more information about Post-Approval Monitoring, please see these links. For human research, see HRPP SOP 306 - Post-Approval Monitoring Standard Operating Procedure; For animal research, see ...

For continuing projects (annual review, three-year renewal), you may not add animals to the study nor buy any additional animals without first getting the IACUC approval. You must get the IACUC ...

Research involving intrusive interventions – for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not ...