GXP

The Corner on Good Science | IVT

The investigation resulted in a determination that FDA could no longer rely on “good faith” by manufacturers and that additional regulations were required to assure that animal safety studies were consistently performed and accurately reported.  As these deficiencies were made public during the Kennedy Hearings of the US Congress (1976), FDA published in 1976 the Proposed Regulations on Good Laboratory Practice (1) becoming effective for nonclinical laboratory studies in 1978.   First published in the Federal Register in November 1976, the stated purpose of the proposed GLP regulations...

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