Tag Archive: waivers

Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Apr 28 2010

New Disclosure Requirements for FDA Advisory Committees

Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into the financial disclosures and conflicts of interest of Advisory Committee members. The FDA has 40 …

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