Tuesday, February 16, 2016

Two Studies Raise Concerns About Efforts to Speed Up FDA’s Drug Approval

Originally published by Robert Kraft.


The Washington Post reports in “Wonkblog” that two new studies raise concerns about the 21st Century Cures Act’s reforms to speed up the Food and Drug Administration’s drug approval process. The first, published in Nature Reviews Drug Discovery, found that early trials of drugs for central nervous system conditions, such multiple sclerosis, were often not predictive of the drug’s ultimate effectiveness. The second, published in BMJ, examined three Alzheimer’s drugs that had encouraging Phase II trials but ultimately failed in Phase III trials when tested with large numbers of patients.

From the news release of the American Association for Justice.

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