
Yale CRRIT
@yale_crrit
Researchers from @YaleMed, @YaleSPH, & @YaleLawSch studying the regulation & coverage of medical drugs & device, advancing policies that improve patient health
ID: 798930507383918592
https://medicine.yale.edu/crrit/ 16-11-2016 16:47:31
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786 Followers
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NEW JAMA Health Forum Special Communication building on the amicus brief filed by Democracy Forward on behalf of Kushal Kadakia, Joseph Ross, & Reshma Ramachandran on the case challenging FDA's LDT Rule, which has now been vacated & not appealed by U.S. FDA. democracyforward.org/work/laboratorâŚ

The U.S. FDA says it will âradically increase efficiencyâ with AI and embrace âradical transparency.â But as Reshma Ramachandran told The New York Times, agency officials recently kicked off a six-city listening tourâwith Pharma CEOsâbehind closed doors. Hereâs the scoop: nytimes.com/2025/06/10/heaâŚ

The U.S. FDA plans to turbocharge drug reviewsâdown to 1-2 months from 10 monthsâvia a new voucher program for âcompanies aligned with U.S. national priorities.â Can the engine handle it? Or will it blow out? @STATNews asked CRRITâs Joseph Ross: đ statnews.com/2025/06/18/fdaâŚ

These 1â2 month reviews may be dangerously fastâeven with a fully staffed FDA. But as Joseph Ross told both @STATNews and Regulatory Affairs Professionals Society, mass layoffs raise real doubts about feasibility. Many key details remain TBD. More via Regulatory Affairs Professionals Society: đ raps.org/news-and-articâŚ

More on the U.S. FDAâs new Commissionerâs National Priority Voucher (CNPV) program: As InsideHealthPolicy paraphrased CRRITâs Reshma Ramachandran, the promised speed âraises serious concerns about the safety and efficacy of drugs rushed to market.â Full story: đ insidehealthpolicy.com/inside-drug-prâŚ

(1/12) New in JAMA Internal Medicine: we assess the performance of U.S. FDA's Breakthrough Devices Program across its first 8 years, with a focus on: â˛ď¸ Review times đĄInnovation đ Evidence CC: Joseph Ross Reshma Ramachandran Harlan Krumholz James Johnston


Surrogate markers are increasingly being used to support U.S. FDA drug approvals instead of measuring clinical outcomes. In a new Federation of American ScientistsđŹ memo, Reshma Ramachandran Joshua D. Wallach & Joseph Ross outline how FDA can make transparent & strengthen their evidence. fas.org/publication/vaâŚ
