This is a skin lotion containing nanoparticles of iron, folate, B12 and vitamin D. Do we need do all nonclinical studies? We would be using amounts close to RDA?
FDA has issued guidance on this: Guidance for Industry—Safety of Nanomaterials in Cosmetic Products—UCM300932. I'd suggest that you read this and if you still have questions talk to the agency. You might not need "all nonclinical studies" but you'd certainly need some and they can help with identifying the ones that would satisfy their requirements for your specific product
I agree with Janice' comments. Extensive non-clinical studies does not seem to be necessary; however minimum investigations including local tolerance of the patch are required to ensure safety of clinicla trial subjects. good luck!
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