Assistant Professor, primary care physician, and health services researcher at Yale School of Medicine, Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT); *views expressed here are my own*
Reshma Ramachandran
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Another instance of a center director acting unilaterally to overrule other staff (which here also involved ignoring FDA's previous statements to the company).
As @reshmagar.bsky.social and I have argued, the bar should be much higher for such unilateral action:
www.nature.com/articles/s41...
See @cmorten.bsky.social's extensive thread on the hearing including a link to he and @reshmagar.bsky.social's new editorial "Politics, Science, and the Future of FDA Drug Regulation: FDA’s Review of Mifepristone REMS as a Litmus Test."
bsky.app/profile/cmor...
New study in @jamanetworkopen.com this week: frequency of post-market safety issues for cancer drugs with accelerated approval.
Happy to collaborate on this study with Dr. Mooghali, @reshmagar.bsky.social @jsross119.bsky.social
jamanetwork.com/journals/jam...
On Wed, Senate HELP will hold a hearing on "Protecting Women: Exposing the Dangers of Chemical Abortion Drugs"—pushing the lie that FDA's regulation has been lax. @reshmagar.bsky.social & I are in @jama.com today, on how FDA has, in fact, been (over-)careful in regulating medication abortion.
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First announced in June, these vouchers are meant to shorten drug review to 2 mos or less. Despite current FDA leadership claiming prior inappropriate industry influence, CRRIT Co-Director @reshmagar.bsky.social noted “cut to now, and it seems like the hen has let the fox into the henhouse.”
🔗 www.statnews.com/2025/12/19/f...
An important piece in @nytimes.com with critical context about why overhauling the US childhood vaccine schedule to match Denmark's is a very bad idea, especially as the White House & politicians continue to strip healthcare access for millions in this country. @drsforamerica.bsky.social #MedSky
Interview with Reshma Ramachandran on changes to the FDA’s adverse-event data releases and future directions for enhancing its safety-surveillance infrastructure. | New England Journal of Medicine
@reshmagar.bsky.social
www.nejm.org/do/10.1056/N...
Classic yet alarming: the federal govt just posted in the Canada Gazette a proposal to fundamentally change drug regulation as we know it.
Here's the link to the Gazette: gazette.gc.ca/rp-pr/p1/202...
If you are following the FDA's new commissioner's national voucher program this post from Paul Kim is a must read...
"No miracles here."
www.linkedin.com/feed/update/...
