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Non‐Biological Complex Drugs
News
FDA approves 40 mg follow-on version of glatiramer acetate
posted 09/03/2018
Sandoz, the generics division of Novartis, announced on 13 February 2018 the approval of its 40 mg follow-on version of... |
Research
Biosimilars and follow-on NBCDs for MS in Europe, the US and Canada
posted 19/01/2018
The advent of biological medicines has significantly transformed the landscapes of many disease spaces and improved the lives... |
Guidelines
US guidelines for follow-on NBCDs
posted 01/06/2018
Last update: 1 June 2018The 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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