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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. Drug discovery and development New pharmaceutical small molecule drugs require extensive safety testing before the manufacturer can obtain regulatory approval for use in humans. million USD.