Obesity Guidance Should Be More Lenient On Indications, Firms Tell FDA
A stipulation that patients should fail lifestyle modifications before they are eligible to enroll in clinical trials for obesity drugs needs to be modified, according to industry comments on an FDA draft guidance on development of weight management drugs
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It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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