CBER regulates biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER reviews new biologics and new indications for approved products. The center requires manufacturers submit scientific and clinical data. CBER’s decision to approve a biologics product is based upon the risks and benefits of the product.
http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Industry/default.htm The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training Branch to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an Investigational New Drug Application (IND) to administer an investigational product to humans.
Research by Margaret Rich
