Home / Non‐Biological Complex Drugs / Polices & Legislation

Polices & Legislation

GDUFA regulatory priorities for 2016 include complex drugs

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.

Is a new pathway for NBCDs on the way in the US?

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 [1].

FDA to set up abbreviated pathway for complex products

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], 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.