FDA – CDER: Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies

This MAPP establishes policies and procedures in the Office of New Drugs (OND) for tertiary review of data from genetic toxicology studies. This MAPP also establishes a Genetic Toxicology Review Committee (GTRC) within OND to perform the tertiary review.

Posted on the FDA website on 25 February 2015

editor2016-12-11T18:37:46+00:0003.03.2015|Regulatory Affairs|

FDA – CDER: Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies

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