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 Zealand Therapeutic Products Agency (ANZTPA)”.  They have released an information…

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 help sponsors and investigators comply with the requirements for investigational…

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,” dated November 2012. The draft guidance document provides sponsors and…