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70,71 Additionally, the exploration of GLP-1R positive allosteric modulators (PAMs) offers a new regulatory approach that could enhance the therapeutic profile of small-molecule GLP-1R agonists

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For evaluating drug products or categories of drug products for inclusion on the DDC list, FDA proposed to establish the following criteria: formulation complexity, drug delivery mechanism complexity, dosage form complexity, complexity of achieving or assessing bioavailability, compounding process complexity, and complexity of physicochemical or analytical testing of the drug product or category of drug products

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