The Governments of Australia and New Zealand are joining forces to regulate (approve and manufacture) “therapeutic products (medicines, medical devices, biological and others) to be administered by the Australia New…

Two new “Guidance for Industry and Investigators” clinical trials documents are available from the FDA.  They include: Safety Reporting Requirements for INDs and BA/BE Studies  This guidance is intended to…

From the FDA: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,”…