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EC addresses issues concerning orphan-drug regulations

DIA Global SmartBrief | Jan 10, 2017

The European Commission has clarified provisions of the EU's Orphan Regulation, addressing such issues as the definition of "significant benefit," application to diseases outside the EU and cases where competing products are assessed at the same time. Regulatory Focus (01/05)


Generic drug group releases plan for collaboration among regulators

DIA Global SmartBrief | Jan 12, 2017

Indian firms shifting US strategy from generics to building brands

DIA Global SmartBrief | Jan 10, 2017

Sanofi, ImmuNext to develop autoimmune antibody

DIA Global SmartBrief | Jan 12, 2017

Denmark bans drug company over falsified expiration labels

DIA Global SmartBrief | Jan 10, 2017

Guidance on CGMP requirements for combo products finalized by FDA

DIA Global SmartBrief | Jan 12, 2017

EMA guidelines for immunoglobulin revised

DIA Global SmartBrief | Jan 12, 2017

Merrimack sells cancer assets, plans staff cuts

DIA Global SmartBrief | Jan 10, 2017

Study: Black patients poorly represented in diabetes trials

DIA Global SmartBrief | Jan 10, 2017

Celgene to develop autoimmune disease drugs with Anokion

DIA Global SmartBrief | Jan 12, 2017


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DIA event highlights

DIA Global SmartBrief | Jan 12, 2017

DIA Pharmacovigilance and Risk Management Strategies Conference, Jan. 23-25, Washington, D.C.

DIA Global SmartBrief | Jan 12, 2017

Last chance to get the early bird rate for the DIA 2017 Annual Meeting!

DIA Global SmartBrief | Dec 29, 2016

What's coming up next? DIA event highlights

DIA Global SmartBrief | Dec 29, 2016




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