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Non‐Biological Complex Drugs

News

Warning letter causes delays for follow-on glatiramer acetate posted 17/03/2017

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17 February 2017 that Sandoz’s contracted fill/fin...

Research

Follow-up studies needed to ensure safety for follow-on NBCDs posted 31/03/2017

Product-specific testing to determine therapeutic equivalence has been an approach used by the US Food and Drug Administratio...

Guidelines

US guidelines for follow-on NBCDs posted 29/07/2016

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Polices & Legislation

FDA to set up abbreviated pathway for complex products 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...

Reports

Equivalence of complex drug products posted 21/04/2017

Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences...

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