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FDA Foreign Trials Proposed Rule Drops Reliance On Helsinki Declaration

Executive Summary

FDA is proposing to revise its requirements for accepting data from foreign trials not conducted under an IND

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FDA Takes Ethics Into Its Own Hands; Foreign Trials Now Subject To Only GCP

FDA is revising its policy on accepting trials conducted abroad, replacing language concerning protections for human subjects to require that firms follow Good Clinical Practice standards instead of adhering to the Declaration of Helsinki

FDA Takes Ethics Into Its Own Hands; Foreign Trials Now Subject To Only GCP

FDA is revising its policy on accepting trials conducted abroad, replacing language concerning protections for human subjects to require that firms follow Good Clinical Practice standards instead of adhering to the Declaration of Helsinki

Complete Response, Harmonization, INDs Rank On FDA Regulatory Agenda

Complete response: FDA plans to finalize its proposed rule to replace "approvable"/"not approvable" letters in response to NDAs with complete response letters in October, according to HHS' spring "unified agenda." The rule is intended to fulfill the 1997 FDA Modernization Act requirement to discontinue "approvable"/"not approvable" letters in favor of a standard format. While complete response letters will still identify deficiencies in an application, they are believed less likely to create overreaction by investors. The proposed rule was issued in July 2004 (1"The Pink Sheet" July 26, 2004, p. 10)...

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