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Non‐Biological Complex Drugs/
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NBCD 2

Equivalence of complex drug products

Non‐Biological Complex Drugs/Reports | Posted 14/04/2017

Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences symposium on Equivalence of Complex Drug Products: Scientific and Regulatory Challenges [1].

Review committee V15a16

Determining the bioequivalence of follow-on iron formulations

Non‐Biological Complex Drugs/Reports | Posted 04/11/2016

Challenges associated with determining the bioequivalence of follow-on iron formulations as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.

Eyedrop Restatis V13H30

Challenges in the assessment of ophthalmic emulsions

Non‐Biological Complex Drugs/Reports | Posted 07/10/2016

Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s (FDA) Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.

NBCD ASEAN V16F09BF S61 V16F20JM

Iron carbohydrate follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 12/08/2016

Follow-on versions of iron–carbohydrate non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27-28 October 2014 [1].

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Glatiramoid follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 11/03/2016

Follow-on versions of glatiramoid non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].

Liposome V15L11

Liposomal follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 11/12/2015

Follow-on versions of liposomal non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].

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Regulations for follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 13/11/2015

Regulations for follow-on versions of non-biological complex drugs (NBCDs) in Europe and the US were discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].

Regulation-V13H16

Status and regulatory issues surrounding follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 05/11/2015

Status and outstanding regulatory issues for follow-on versions of non-biological complex drugs (NBCDs) were discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].