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...

Etanercept biosimilar submitted for approval in... Biosimilars/News | Posted 17/02/2017
Regional management of biosimilars in Germany Biosimilars/Research | Posted 17/02/2017
Generics and brand-name drugs compared Generics/Research | Posted 17/02/2017
Positive results for Pfizer’s adalimumab biosim... Biosimilars/Research | Posted 17/02/2017
Novo Nordisk becomes second pharma company to c... Generics/General | Posted 17/02/2017
Joint 23rd Medicines for Europe and 20th IGBA A... Conferences | Posted 17/02/2017
Biosimilars in 2016: the highlights Biosimilars/General | Posted 10/02/2017
EMA approval for adalimumab biosimilars Amgevit... Biosimilars/News | Posted 10/02/2017
Switching stable kidney transplant patients to... Generics/Research | Posted 10/02/2017
Positive phase III results for adalimumab biosi... Biosimilars/Research | Posted 10/02/2017
New FDA guidance to speed up generics approvals Guidelines | Posted 10/02/2017
Position statement on approval of biosimilars i... Biosimilars/Research | Posted 10/02/2017
Sandoz withdraws biosimilar pegfilgrastim appli... Biosimilars/News | Posted 03/02/2017
US Supreme Court to review 180-day notice for b... Policies & Legislation | Posted 03/02/2017
Assessing structural comparability using NMR Biosimilars/Research | Posted 03/02/2017
EMA to launch pilot for tailored advice on bios... Biosimilars/General | Posted 03/02/2017
Biosimilars and treatment of IBD in Italy Biosimilars/Research | Posted 03/02/2017
Patent and regulatory exclusivities driving gen... Generics/Research | Posted 03/02/2017
FDA issues final guidance on naming biologicals Guidelines | Posted 27/01/2017
EC publishes improved biosimilars information f... Biosimilars/General | Posted 27/01/2017
Boehringer Ingelheim submits biosimilar adalimu... Biosimilars/News | Posted 27/01/2017
UK fines Pfizer and Flynn following epilepsy dr... Policies & Legislation | Posted 27/01/2017
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
EMA approval for rituximab biosimilar Truxima Biosimilars/News | Posted 20/01/2017
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
Benepali gains approval for extra indications Biosimilars/News | Posted 13/01/2017
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
Colombia slashes price of cancer treatment Glivec Policies & Legislation | Posted 13/01/2017
Positive phase III results for adalimumab and t... Biosimilars/Research | Posted 13/01/2017
Mylan launches generic EpiPen Generics/News | Posted 13/01/2017
Top 10 most read GaBI Online articles in 2016 Pharma News | Posted 06/01/2017


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

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


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