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
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...
Reshma Ramachandran
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...
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...
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...
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...
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.”
Doctors for America
Doctors for America
Holly Fernandez Lynch
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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🔗 www.statnews.com/2025/12/19/f...
The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making authority of individ...
