publication . Article . 2002

Policy developments in regulatory approval

Robert Temple;
Open Access
  • Published: 09 Oct 2002
Although radical changes in drug regulation are rare (e.g., the Federal Food, Drug and Cosmetic Act of 1938 and the 1962 amendment to the Act creating an effectiveness requirement), regulations and guidance do evolve significantly in the face of new problems and accumulating experience. Recent changes have been driven by the Food and Drug Administration Modernization Act (FDAMA), user fee legislation, the International Conference on Harmonization, recent safety related drug withdrawals, and concerns about trial ethics and investigator conflict of interest. FDAMA and guidance developed in response to it has helped circumstances in which FDA would rely on a single...
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free text keywords: Public policy, Risk management, business.industry, business, User fee, Legislation, Conflict of interest, Drug development, Risk assessment, Medicine, Public relations, Clinical trial, Operations research
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