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During the three-year shortage period, Hims & Hers, along with many other companies, began selling a compounded version of the drug, capturing profits that would be typically foreclosed by competitor Novo Nordisks patents

Because of the increased requirements applicable to these types of studies, it is critical that companies conducting these studies carefully structure their drug development programs to ensure that all studies are appropriately capturing the level of detail and thoroughness which FDA will require when reviewing an NDA

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