Posts from October 15, 2012

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Approval pathway proposed for significant drug combinations

Earlier this month, US Congressional Representatives Brian Bilbray (R-CA, Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT) introduced House Resolution 6502, the Life-Threatening Diseases Compassion through Combination[…]

What are the Kefauver-Harris amendments?

October 2012 marks 50 years since the passage of the Kefauver-Harris Drug Act of 1962, known less formally as the Kefauver-Harris drug amendments. The bill, named[…]