FDA/CDER - HESI Immunomodulators and Pregnancy Risk Assessment Workshop

This workshop is a joint effort between the US Food and Drug Administration (FDA) and the Health and Environmental Science Institute (HESI) - FDA’s mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and the safety and security of our nation’s food supply, cosmetics, and products that emit radiation. FDA also advances the public health by helping to speed innovations that make medicines more effective and affordable and safe. As part of these goals, FDA’s CDER and CBER seeks to protect and enhance the public health through the regulation of drugs, biologicals, and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. -Health and Environmental Sciences Institute (HESI) was established in 1989 to provide an international forum to advance the understanding of scientific issues related to human health, toxicology, risk assessment, and the environment. In 2002, the U.S. Internal Revenue Service granted HESI tax-exempt status as a publicly supported, independently charted, charitable scientific organization pursuant to Section 501(c)(3) of the Internal Revenue Code. HESI’s scientific programs bring together scientists from around the world to address human and environmental health issues.