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Making a determination regarding drug shortage status in a declaratory order issued as a product of informal adjudication is well within FDAs discretion under the FD&C Act and the APA, the letter stated

Adoption of GLP-1s can be rapid in India, given India has over 100 million obese adults and another 180 million overweight individuals

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Treatment continuation criteria under NICE guidance require at least 5% weight loss after 6 months of treatment at the maintenance dose