Tag: drug approval process
New Alzheimer’s Drug Approval Could Change the FDA’s Approval Process for the Better
After the experimental treatment for Alzheimer’s named aducanumab failed a futility test, its producers Biogen and Eisai lost hope the Food and Drug Administration would ever approve it. Despite promising clinical results through the approval process, the producers abandoned their project in 2019.  Eight months later, Biogen developed an expanded dataset to reassess aducanumab’s impact...
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Right-to-Try Laws Can Help Drugmakers Combat the Coronavirus
President Trump recently announced he is extending social distancing guidelines to April 30th. He initially hoped to lift them by Easter. This is far from the first time he has changed his mind on how to best handle the coronavirus pandemic. Although frustrating, the President’s indecisiveness is understandable. The United States recently surpassed China...
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FDA Approves Record Number of Generic Drugs in 2018
With U.S. drug prices among the highest in the world, generics provide significant financial relief for millions using prescription drugs.
Good and Bad News on Generic Drug Approvals
A solution to expensive patented medicines is generic competitors. The United States has struck a pretty good balance between innovation and low prices through the Hatch-Waxman (1984) Act, which specified patent terms for newly invented medicines, and a pathway for generic competitors to enter the market after a period. One obstacle to generic entry...
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