Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for patients with a specific molecular sub-type.
These more targeted treatments often address unmet medical needs. They can represent significant improvements over the prior standard of care.
This medical progress is the result of scientific advancement. But it’s also a consequence of a bipartisan consensus that has supported investments in medical research and a modern regulatory process to advance safe and effective therapies.
