Non‐Biological Complex Drugs/
Polices & Legislation
As part of the Generic Drug User Fee Amendments (GDUFA) of 2012, the US Food and Drug Administration (FDA) committed to prepare a yearly list of regulatory science priorities for generics based on input from industry and other stakeholders.
The US Food and Drug Administration (FDA) does not formerly recognize non-biological complex drugs (NBCDs), with originators required to follow the new drug application (NDA) route and follow-on NBCDs using the generics – abbreviated new drug application (ANDA) – route .
As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry , the US Food and Drug Administration (FDA) has committed to setting up a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.