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Under the reauthorization of GDUFA in 2022 (GDUFA III), the FDA made a commitment to assist industry in the submission of abbreviated new drug applications (ANDA) for complex drug products, defined as those with a complex active ingredient, route of delivery, dosage form or formulation, drug-device combination and/or products for which the choice of an approval pathway would benefit from early scientific engagement (MAPP 5240.10)

Both models showed positive responses

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Bulk RNA sequencing revealed that gene expression changes were most pronounced in the MBH, where RAMP1/3 KO mice treated with sCT showed extensive differential expression of over 1,700 genes, while WT mice exhibited comparatively minor transcriptional shifts

Biessels GJ, Kamal A, Urban IJA, Spruijt BM, Erkelens DW, Gispen WH (1998) Water maze learning and hippocampal synaptic plasticity in streptozotocin-diabetic rats: effects of insulin treatment