FDA rejects petitions over biologicals naming guideline

Posted 17/02/2017

The US Food and Drug Administration (FDA) has rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary n...

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EC publishes improved biosimilars information f... Biosimilars/General | Posted 27/01/2017
Boehringer Ingelheim submits biosimilar adalimu... Biosimilars/News | Posted 27/01/2017
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European IBD specialists support switching to b... Biosimilars/General | Posted 27/01/2017
Generics regulators outline priorities to 2020 Generics/General | Posted 27/01/2017
What makes physicians consider patients suitabl... Biosimilars/Research | Posted 27/01/2017
Endo launches generic version of Zetia Generics/News | Posted 27/01/2017
European oncologists back biosimilars with posi... Biosimilars/General | Posted 20/01/2017
Generics applications under review by EMA – Dec... Generics/General | Posted 20/01/2017
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Natco Pharma and Alvogen launch first US Tamifl... Generics/News | Posted 20/01/2017
What internists should know about biologicals a... Biosimilars/Research | Posted 20/01/2017
SMi 9th Adaptive Designs in Clinical Trials 2017 Conferences | Posted 20/01/2017
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UK competition authority accuses Actavis of ove... Generics/General | Posted 13/01/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 13/01/2017
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Positive phase III results for adalimumab and t... Biosimilars/Research | Posted 13/01/2017
Mylan launches generic EpiPen Generics/News | Posted 13/01/2017
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NON-BIOLOGICAL COMPLEX DRUGS

Non-biological complex drugs and pharmacopoeias Posted 10/02/2017

Pharmacopoeias, as standard references for pharmaceutical drug specifications...

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In vitro analysis of follow-on versions of seve... Non‐Biological Complex Drugs/Research | Posted 18/11/2016
Determining the bioequivalence of follow-on iro... Non‐Biological Complex Drugs/Reports | Posted 04/11/2016
FDA to set up abbreviated pathway for complex p... Non‐Biological Complex Drugs/Polices & Legislation | Posted 21/10/2016
Challenges in the assessment of ophthalmic emul... Non‐Biological Complex Drugs/Reports | Posted 07/10/2016
Cancer lab to evaluate bioequivalence of nanosi... Non‐Biological Complex Drugs/News | Posted 23/09/2016
A conference on ‘Equivalence of Complex Drug Pr... Non‐Biological Complex Drugs/News | Posted 09/09/2016
Collaboration to introduce nanotechnologies in... Non‐Biological Complex Drugs/News | Posted 26/08/2016
Iron carbohydrate follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 12/08/2016
Rigorous approach used to approve a follow-on v... Non‐Biological Complex Drugs/Research | Posted 29/07/2016
US guidelines for follow-on NBCDs Non‐Biological Complex Drugs/Guidelines | Posted 10/06/2016
Non-biological complex drugs and their follow-o... Non‐Biological Complex Drugs/Research | Posted 03/06/2016
Is a new pathway for NBCDs on the way in the US? Non‐Biological Complex Drugs/Polices & Legislation | Posted 27/05/2016
Follow-on glatiramer acetate gains European app... Non‐Biological Complex Drugs/News | Posted 13/05/2016
FDA includes follow-on versions in its new cycl... Non‐Biological Complex Drugs/Guidelines | Posted 29/04/2016
Switching between originator and follow-on iron... Non‐Biological Complex Drugs/Research | Posted 22/04/2016
Follow-on intravenous iron formulations in haem... Non‐Biological Complex Drugs/Research | Posted 01/04/2016
Glatiramoid follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 11/03/2016
FDA includes follow-on versions in its new lipo... Non‐Biological Complex Drugs/Guidelines | Posted 26/02/2016
EU guidelines for follow-on NBCDs Non‐Biological Complex Drugs/Guidelines | Posted 22/01/2016
GDUFA regulatory priorities for 2016 include co... Non‐Biological Complex Drugs/Polices & Legislation | Posted 11/12/2015
Liposomal follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 11/12/2015
Regulations for follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 13/11/2015
Status and regulatory issues surrounding follow... Non‐Biological Complex Drugs/Reports | Posted 05/11/2015
Follow-on glatiramer acetate (M356) claimed as... Non‐Biological Complex Drugs/Research | Posted 05/11/2015
EMA issues reflection paper for follow-on versi... Non‐Biological Complex Drugs/Guidelines | Posted 05/11/2015
FDA approves first follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 05/11/2015
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