FDA+ roundup: New draft guidance on therapeutic equivalence; Cavazzoni talks accelerated approvals
The FDA on Wednesday released new draft guidance spelling out exactly how it conducts therapeutic equivalence (TE) evaluations for generic and follow-on drugs.
The 14-page draft, which ends with 14 frequently asked questions related to TE, initially explains how the scientific and regulatory foundation for the evaluation of TE involves three main components: Pharmaceutical equivalence, bioequivalence, and establishing the same clinical effect and safety profile for the conditions of use as specified in the label.
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