FDA fi­nal­izes guid­ance clos­ing pe­di­atric study loop­hole

The FDA on Thurs­day fi­nal­ized guid­ance stat­ing that it does not in­tend to grant or­phan drug des­ig­na­tion for pe­di­atric sub­pop­u­la­tions of com­mon dis­eases in an …

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