Center For Drug Evaluation and Research History
Federal regulation of drugs emerged as early as 1848, under a law that addressed only imported drugs. In 1905 the American Medical Association launched a private, voluntary means of controlling a substantial part of the drug marketplace, a system that remained in place for over a half-century. Drug regulation in FDA has evolved considerably since President Theodore Roosevelt signed the 1906 Pure Food and Drugs Act.
In CDER, the Ombudsman has responsibilities in addition to resolving disputes. These include getting feedback from inside and outside the Center about the effectiveness of programs and about problems that impede CDER's performance of its mission or conflict with its values/operating principles. The Ombudsman also advises the Center Director on ways to correct such problems.