Perspective

Regulatory professionals have the opportunity to work in unique situations and the desire to share their experiences so others can benefit. Perspective offers an insider’s eye into the workings of the regulatory profession.

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16 April 2012

Perspective: A Modern Progressive Approval System for Rare Diseases

By Marc Dunoyer

The recent dramatic increase in the number of orphan drug designations has prompted patient groups, pharmaceutical companies, legislators and many other stakeholders to look for ways to accelerate the delivery of innovative new medicines to people with rare diseases. In particular, patients suffering from illnesses for which there are no adequate licensed therapies want access to promising new products earlier in the drug development cycle. [Read More...]


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