Future perspectives of regulations in the United States
The legal basis for the regulatory framework in the United States was initiated in 1938 and underwent major changes in 1962, when the concept of adequate, well-controlled studies for providing evidence of effectiveness was introduced. Major revisions of the NDA regulations in 1985 and of the IND regulations in 1987 improved and clarified, but did not fundamentally alter the regulatory process.
The current arrangement of law and regulation in the US appear to be acceptable to most people and unlikely to undergo major changes in the near future.
The regulatory environment, created by the activities and attitudes of congressional committees, academic and lay public, is often as important as the law and regulations. The major concern, in the light of the AIDS epidemic, is that delay be eliminated, allowing significant drugs to become available promptly. FDA has responded to this concern in three ways.
The regulatory environment appears stable although the consensus amongst the regulators, the regulated industry and observers, is that the review and approval process still takes too long. Steps are being taken to rectify this problem.
Of particular scientific interest in the future, will be increased investigation of dose-response relationships and individual variability in pharmacokinetics.
It appears that, in regulatory terms, Europe and the United States are growing more alike.
KeywordsRegulatory Environment Wall Street Journal Approval Process Current Arrangement Major Revision
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