Fillable section 505 u of fdca form

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2 The FDA defines a new chemical entity NCE as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505 b of the FDCA. 3 According to the FDA NCEs are by definition innovative and represent significant changes from already-approved drug products Kyle Faget is a patent litigation associate at Ropes and Gray in Boston. Food and Drug Administration...
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section 505 u of fdca
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