About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

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CRITical Thinking Blog

Improvement in publication bias following the 2007 FDA Amendment Act

July 26, 2017
By Adam T. Phillips, Joseph S. Ross

With publication bias being a huge issue in medical literature, policies that set out to mitigate bias, such as the 2007 FDA Amendment Act, are certainly welcome. But just how effective has this policy been in improving the transparency of trial publication?

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Facing the Challenges Confronting the Food and Drug Administration (FDA) Under the Trump Administration

June 21, 2017
By Margaret McCarthy, Gregg Gonsalves

The federal Food and Drug Administration is at a crossroads.

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Scott Gottlieb and the Standards of FDA Approval

May 3, 2017
By Jeanie Kim, Joshua D. Wallach

Dr. Scott Gottlieb—Donald Trump’s pick to lead the Food and Drug Administration (FDA)—has been praised and criticized for having worn many hats during his career.

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FDA Regulatory Review: It’s still faster

April 6, 2017
By Audrey D. Zhang, Nicholas S. Downing, Joseph S. Ross

The speed with which the Food and Drug Administration (FDA) reviews new drug, biologic and medical device applications remains a contentious subject of criticism. And with attention focused on the impending reauthorization of the Prescription Drug User Fee Act (PDUFA), it’s worth revisiting the commonly heard rhetoric that FDA regulatory review is too slow.

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