Overview This guidance is intended to assist clinical investigators, sponsors, sp...

Overview This guidance is intended to assist clinical investigators, sponsors, sp...

Overview If you are working with or planning to work with an investigational agen...

Overview The FDA has a complex and extensive set of requirements for sponsor-inve...

Overview The U-M Research Pharmacy is a  service provided by the Department of Ph...

Overview If you are conducting a study with an investigational agent, the Centers...