GDUFA regulatory priorities for 2016 include complex drugs

Non‐Biological Complex Drugs/Polices & Legislation | Posted 11/12/2015 post-comment0 Post your comment

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.

Regulation V13H16

In the agency’s list for 2016, the FDA’s Office of Generic Drugs has listed equivalence of complex drug products as one of its priorities.

Equivalence of complex drug products includes research into making generics available in all product categories, including complex drugs with unique characteristics. FDA says that it is spending an increasing amount of time reviewing and developing policy for complex drug products, and future generics will need to demonstrate equivalence to increasingly complex reference drugs.

This scientific research supports the development of guidance and policy that clarifies the abbreviated new drug application (ANDA) pathway for complex products such as drug-device combinations, transdermal systems, implants and parenteral microspheres, nanomaterials, e.g. liposomes and iron colloids, and products that contain complex mixtures and peptides. New priorities for financial year 2016 include transdermal irritation studies and research into human factors studies that will aid in evaluation of product substitutability and robustness for drug-device combinations.

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Source: US FDA

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