Data Requirements

Will submission of genotoxicity studies be necessary for polymeric substances, in addition to starting monomers used to make the polymer (where exposure is between 0.5 ppb and 50 ppb)?

Mar 2001

Question: Will submission of genotoxicity studies be necessary for polymeric substances, in addition to starting monomers used to make the polymer (where exposure is between 0.5 ppb and 50 ppb)?

Answer: The agency has been quite flexible in these circumstances. In several instances, our clients have submitted the required genotoxicity studies on starting monomers, and where these raise no significant issues, FDA has not insisted on the full battery of genotox studies on the polymer per se.

FDA appears to agree with the scientific community that polymers and even oligomers do not pose significant toxicology concerns if their monomers have been tested satisfactorily.

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