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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40
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The evolution of assays for immuno-oncology research

Drug Discovery World

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. 90, 297–339 (2006). Strategic Market Research Report; Immuno-oncology Assays Market Size, Trend Analysis 2030.

Research 130
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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

In 2006, the ICH released its S8 Guideline on Immunotoxicity Studies for Human Pharmaceuticals , which provided recommendations on how companies should test pharmaceuticals for “unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.”

FDA 40