FDA issues final guidance on bioanalytical method validation

Posted 25/05/2018

On 21 May 2018, the US Food and Drug Administration issued final guidance on bioanalytical method validation.

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EC approval for infliximab biosimilar Zessly Biosimilars/News | Posted 25/05/2018
New chemical entities added to ACSS work-sharin... Policies & Legislation | Posted 25/05/2018
Encouraging generics could cause high prices Generics/Research | Posted 25/05/2018
Hetero launches adalimumab similar biologic in... Biosimilars/News | Posted 25/05/2018
Price of leukaemia drug in Japan halved Generics/News | Posted 25/05/2018
Utilization data and cost-effectiveness of infl... Biosimilars/Research | Posted 25/05/2018
Pegfilgrastim biosimilar Lapelga approved in Ca... Biosimilars/News | Posted 18/05/2018
FDA approves epoetin alfa biosimilar Retacrit Biosimilars/News | Posted 18/05/2018
TGA proposes changes to biologicals regulations Guidelines | Posted 18/05/2018
Brazilian oncologists favour ‘follow-on biologi... Biosimilars/Research | Posted 18/05/2018
Sanofi to sell Zentiva generics arm to Advent Pharma News | Posted 18/05/2018
Biosimilars substitution bill becomes law in So... Policies & Legislation | Posted 18/05/2018
Hikma launches HIV generic ritonavir in the US Generics/News | Posted 18/05/2018
Secrecy is an obstacle to the use of biosimilar... Biosimilars/Research | Posted 11/05/2018
Biosimilar etanercept Eucept approved in South... Biosimilars/News | Posted 11/05/2018
Safety of biosimilar infliximab in pregnant wom... Biosimilars/Research | Posted 11/05/2018
Biosimilars highlights for 2017 Biosimilars/General | Posted 11/05/2018
EMA collaboration on oversight of API makers Generics/General | Posted 11/05/2018
China introduces new policy to boost generics Policies & Legislation | Posted 11/05/2018
Alvogen receives European approval for generic... Generics/News | Posted 11/05/2018
Insurance payment arrangements are an obstacle... Biosimilars/Research | Posted 04/05/2018
FDA rejects trastuzumab and rituximab biosimilars Biosimilars/News | Posted 04/05/2018
Trends in use of Lipitor after introduction of... Generics/Research | Posted 04/05/2018
Biosimilars in rheumatology: the current state... Biosimilars/Research | Posted 04/05/2018
Canadian health committee proposes National Pha... Policies & Legislation | Posted 04/05/2018
AbbVie and Samsung Bioepis reach patent deal ov... Biosimilars/General | Posted 04/05/2018
Interchangeability is an obstacle to the use of... Biosimilars/Research | Posted 27/04/2018
Australia approves rituximab biosimilar Truxima Biosimilars/News | Posted 27/04/2018
Phase I study of biosimilar trastuzumab demonst... Biosimilars/Research | Posted 27/04/2018
Fujifilm to acquire cell culture media companies Pharma News | Posted 27/04/2018
Oregon introduces pricing transparency bill Policies & Legislation | Posted 27/04/2018
Teva launches ulcerative colitis generic in the US Generics/News | Posted 27/04/2018
Regulation of biologicals in Colombia Guidelines | Posted 20/04/2018
FDA rejects Celltrion/Teva’s rituximab and tras... Biosimilars/News | Posted 20/04/2018
Interchangeability for biosimilars Reports | Posted 20/04/2018
Switchback rates between generic and brand-name... Generics/Research | Posted 20/04/2018
Afucosylated biosimilars: the path to matching... Biosimilars/Research | Posted 20/04/2018
CFDA to come under national market supervision... Policies & Legislation | Posted 20/04/2018
Naming is an obstacle to the use of biosimilars... Biosimilars/Research | Posted 20/04/2018
Generics companies defend against illegal ‘pay-... Generics/General | Posted 20/04/2018
Obstacles to the use of biosimilars in the US Biosimilars/Research | Posted 13/04/2018
EMA approval for infliximab biosimilar Zessly Biosimilars/News | Posted 13/04/2018
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NON-BIOLOGICAL COMPLEX DRUGS

FDA issues final guidance on liposome drug products Posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft...

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FDA approves 40 mg follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 09/03/2018
Mylan launches first follow-on glatiramer aceta... Non‐Biological Complex Drugs/News | Posted 15/02/2018
Biosimilars and follow-on NBCDs for MS in Europ... Non‐Biological Complex Drugs/Research | Posted 19/01/2018
Impax announces FDA approval of follow-on sevel... Non‐Biological Complex Drugs/News | Posted 17/11/2017
FDA approves follow-on version of sevelamer Non‐Biological Complex Drugs/News | Posted 30/06/2017
Challenges in the regulation of NBCDs Non‐Biological Complex Drugs/Research | Posted 12/05/2017
Scientific and regulatory considerations for fo... Non‐Biological Complex Drugs/Research | Posted 05/05/2017
Equivalence of complex drug products Non‐Biological Complex Drugs/Reports | Posted 14/04/2017
Follow-up studies needed to ensure safety for f... Non‐Biological Complex Drugs/Research | Posted 31/03/2017
Warning letter causes delays for follow-on glat... Non‐Biological Complex Drugs/News | Posted 17/03/2017
Is the EU ready for non-biological complex drug... Non‐Biological Complex Drugs/Research | Posted 03/03/2017
Follow-on versions of glatiramer acetate in Rus... Non‐Biological Complex Drugs/News | Posted 24/02/2017
Non-biological complex drugs and pharmacopoeias Non‐Biological Complex Drugs/Research | Posted 10/02/2017
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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