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Non‐Biological Complex Drugs

News

Cancer lab to evaluate bioequivalence of nanosimilars posted 23/09/2016

The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collabor...

Research

Follow-on intravenous iron formulations in haemodialysis patients posted 11/02/2017

A study into the efficiency of follow-on intravenous (IV) iron formulations compared to originator formulations in haemodialy...

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

Challenges in the assessment of ophthalmic emulsions posted 18/11/2016

Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs)...