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Politics, Policy & Law

It’s complicated: generics companies want FDA to simplify path for complex generics 

GDUFA reauthorization as vehicle for making FDA guidance more frequent and consistent

GDUFUA reauthorization could be a vehicle for making FDA guidance more frequent and consistent.

Mar 5, 2021 | 12:46 AM GMT

Stalemated applications for FDA approvals of generic versions of complex non-biologic drugs are sucking money out of the U.S. healthcare system, depleting resources that are needed to create headroom for spending on innovative drugs.

Complex generics are non-biologic drugs with a complex active ingredient, formulation or route of administration that makes it more difficult than a small molecule drug to determine bioequivalence with a reference product.

Overcoming barriers to approval of complex generics may be difficult, but it isn’t difficult to understand the consequences of continuing to allow drug companies to maintain de facto monopolies long after patents expire. Advances in regulatory science and policies are needed to ensure drops in prices and associated increased access

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