FDA's Hamburg open to speedy trials for drugs with risks

After the President's scientific advisers backed a plan that could double drug approvals, the FDA showed a willingness to work on a new way for certain drugs with "special medical use" to rapidly advance through trials. The special label could apply to obesity treatments and new antibiotics, among other meds, speeding them to the market for defined groups of patients with dire needs for the therapies and a full understanding of the risks. "This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances," FDA Commissioner Dr. Margaret Hamburg said in a recording of a meeting, as quoted by Bloomberg. There are still details to be worked out for the idea to become reality, but the prospect of doubling drug approval rates could help an industry in need of new products to replace older ones going off patent. Article


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