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Posted by Michael Wonder on 21 Nov 2019

FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

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Posted by Michael Wonder on 17 May 2018

FDA faster than global peers at approving new drugs

16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...

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Posted by Michael Wonder on 26 Apr 2018

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada

26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...

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Posted by Michael Wonder on 16 Nov 2017

Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS

15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...

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Posted by Michael Wonder on 06 Jun 2017

Workshop: addressing unmet needs of children with pulmonary arterial hypertension

6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...

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