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Non‐Biological Complex Drugs/
Polices & Legislation

Regulation V13H16

GDUFA regulatory priorities for 2016 include complex drugs

Non‐Biological Complex Drugs/Polices & Legislation | Posted 11/12/2015

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.

NBCD 2

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

Non‐Biological Complex Drugs/Polices & Legislation | Posted 27/05/2016

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].

20 AA010933

FDA to set up abbreviated pathway for complex products

Non‐Biological Complex Drugs/Polices & Legislation | Posted 21/10/2016

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.