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## Abstract 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 study to support effectiveness and the circumstances in which surrogate endpoints could support approval. An ICH Document ‘Choice of control group and related design issues in clinical trials’ focussed attention on the ethics of placebo controls (acceptable, even if there is existing therapy, when the placebo‐treated patient will suffer no irreversible injury) and the design of ‘equivalence’ or ‘non‐inferiority’ trials. There has been greatly increased attention to obtaining good dose‐response information and to

Who reads Policy Developments in Regulatory Approval?

Author

Robert Temple

Publisher

John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0277-6715)

Published

2002

Language

EN

Field

Mathematics (Physical Sciences)