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Title    Safety of Drugs Approved by FDA Surveyed
Date    Sunday May 14 2017, @12:03PM
Author    cmn32480
Topic   
from the cheap,-fast,-safe,-pick-two dept.
https://soylentnews.org/article.pl?sid=17/05/14/0132239

butthurt writes:

Kaiser Health News reports on work published in the Journal of the American Medical Association (DOI: 10.1001/jama.2017.5150). In the journal article, the researchers concluded that

Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events [...]

According to the Kaiser Health News article, the 21st Century Cures Act, enacted in December,

[...] offers ways to speed drug approval by pushing the FDA to consider different kinds of evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for more unsafe approvals.

additional coverage:

Original Submission

Links
  1. "butthurt" - https://soylentnews.org/~butthurt/
  2. "Kaiser Health News reports" - http://khn.org/news/1-in-3-recent-fda-drug-approvals-followed-by-major-safety-actions/
  3. "Journal of the American Medical Association" - https://jamanetwork.com/journals/jama/article-abstract/2625319
  4. "10.1001/jama.2017.5150" - https://dx.doi.org/10.1001/jama.2017.5150
  5. "21st Century Cures Act" - https://en.wikipedia.org/wiki/21st_Century_Cures_Act
  6. "Yale University press release" - http://news.yale.edu/2017/05/09/new-safety-concerns-identified-1-3-fda-approved-drugs
  7. "AP via WCRB-TV" - http://www.wrcbtv.com/story/35382748/study-side-effects-emerge-after-approval-for-many-us-drugs
  8. "Fortune" - http://fortune.com/2017/05/09/fda-approval-safety-concerns/
  9. "CNN" - http://edition.cnn.com/2017/05/09/health/fda-approval-drug-events-study/
  10. "San Diego Union-Tribune" - http://www.sandiegouniontribune.com/business/biotech/sd-me-drug-safety-20170509-story.html
  11. "MedPage Today" - https://www.medpagetoday.com/publichealthpolicy/fdageneral/65139
  12. "Original Submission" - https://soylentnews.org/submit.pl?op=viewsub&subid=20177
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