Contains a variety of policy and regulatory guidance materials to assist the research community. The Index provides a grid with pertinent guidelines about clinical trials
Contains legal, news, and business-related subjects. Newspapers & legal materials are featured, including cases, statutes, and regulations of the U.S. government and the various state governments; includes the legal encyclopedia American Jurisprudence 2nd and American Law Reports; case law from 1789 to present; current statutes and regulations.
These programs give FDA staff additional resources to conduct more reviews for new drugs and devices. The Amendment also expanded the requirement for reporting Clinical Trials (section 801) and reauthorized two additional acts that directly affect research and development in treatments for children.
