Joseph Ross

Carla Godoy and colleagues examined recent FDA approvals based on a single pivotal trial, finding that only 20% had referenced confirmatory evidence, though this proportion increased markedly after 2019 FDA guidance. #DrugApprovals @SCTorg @YaleMed @jsross119 @FDA #FDA

How should Medicare cover emerging technologies? In @NEJM, we analyze the tension lawmakers are facing between access, clinical uncertainty, and cost as Congress once again debates this question (1/9) cc: @Yale_CRRIT @HouseCommerce @SenateFinance @MedTechDive @KatieMPalmer

Nice analysis by @KatieMPalmer in @statnews on the debate before Congress regarding Medicare coverage of breakthrough devices: statnews.com/2026/01/14/med…

Tonight, @LSEHealthPolicy is announcing the launch of the Pharmaceutical Policy Lab. We are live with a discussion on different health technology assessment systems - with Foluso Agboola, Emily Jackson, Beate Wieseler & Huseyin Naci. Join us: youtube.com/watch?v=QERCNa… #LSEEvents

(1/9) Last week, the @USGAO published the results of its yearlong audit of @US_FDA's medical device recall process. The results underscore the need for action on medical device safety: gao.gov/products/gao-2…

The authors of a new Perspective write that the FDA recently announced that it will be releasing daily drug adverse-event data. But questions remain about how it will manage frequent releases and how the public may interpret released information. Read the Perspective by @JoshuaDWallach, PhD, Joseph S. Ross, MD, MHS (@jsross119), and Reshma Ramachandran, MD, MPP, MHS (@reshmagar): nej.md/4pWXLgb

We are excited to share a recently published article in @JAMAInternalMed investigating postmarket drug safety actions before and after the 2007 @US_FDA and Drug Administration Amendments Act (FDAAA) (1/9)

Such a pleasure to attend #congresosmeo2025 & speak with outstanding early career oncologists @SMEOMX, along with @DrNDisis @JAMAOnc & @jsross119 @JAMA_current

We were honored to welcome Dr. Mandy Cohen, former CDC Director and former North Carolina Secretary of Health and Human Services, to meet with our Yale NCSP community. Thank you, Dr. Cohen, for inspiring the next generation of clinician scholars. #YaleNCSP #HealthcareLeadership

We need a new generation of academic leaders and institutions/funders who value efficiency and a diverse array of research contributions over pub counts. This @AnnalsofIM essay was so much fun to write with @ADetsky @jsross119 + CBooth(@QueensuSCRI) acpjournals.org/doi/10.7326/AN…

Delighted to share my 1st publication in @JAMAHealthForum, exploring the patient safety implications of @US_FDA-regulated, AI-enabled medical devices: jamanetwork.com/journals/jama-… Our study finds AI devices, especially those developed by publicly traded companies, are significantly more likely to be recalled. Many of these tools were never tested on patients before entering clinical use. Publicly traded companies, the big fish in this still-small pond, developed just over half of the devices but were responsible for nearly all of the recalls. We were stunned to find that almost half of all AI device recalls occurred within the first year after approval. Even more concerning: 95% of these recalls involved tools with no reported clinical validation. If AI hasn’t been tested on people, then people become the test. Our team, spanning @HopkinsMedicine, @JHUCarey, @JohnsHopkinsSPH, @YaleMed, and @GUMedicine, examined nearly 1,000 @US_FDA-cleared AI devices. Grateful to Branden Lee, who brilliantly led our phenomenal group of @JohnsHopkins medical students—Patrick Kramer, Sara Sandri, Ritika Chanda, @CrystalFavorito, and Olivia Nasef—and to co-authors Drs. @jsross119 and @drJoshS.

5. Novelist David Baldacci had a remarkable statement last week in the Senate Judiciary Committee. He points out that AI firms would fight violations of their source code copyright, but seem to have no problem violating his.

High brand-name drug prices fall once a generic enters the market. In a new @JournalGIM article, @rgupta729, CRRIT Co-Director @jsross119, and colleagues from @PORTAL_Research assess associations between patents, revenue, and generic competition.

Here is the full letter Comey, the daughter of former FBI director James Comey, sent to colleagues: politico.com/news/2025/07/1…

Surrogate markers are increasingly being used to support @US_FDA drug approvals instead of measuring clinical outcomes. In a new @scientistsorg memo, @reshmagar @JoshuaDWallach & @jsross119 outline how FDA can make transparent & strengthen their evidence. fas.org/publication/va…

This is an excellent article that explains these issues, and the ongoing assault on the FDA, and the perspectives of people like @reshmagar who have pushed to reform the FDA in their work but who are now fighting to save it from these depredations. nytimes.com/2025/07/08/mag…

Proud to celebrate our Yale NCSP 2025 graduates! 🎉 Their leadership & commitment to improving healthcare will make a real difference. #NCSP #YaleNCSP

🎓 Celebrating Yale NCSP grads Alissa Chen, MD, MPH, joining Yale as Instructor of Medicine, and Anand Habib, MD, MPhil, heading to UCSF as Assistant Professor of Hospital Medicine! We can’t wait to see them lead, innovate, and improve care. #YaleNCSP #NCSP #healthcareleadership

(1/12) New in @JAMAInternalMed: we assess the performance of @US_FDA's Breakthrough Devices Program across its first 8 years, with a focus on: ⏲️ Review times 💡Innovation 📊 Evidence CC: @jsross119 @reshmagar @hmkyale @JLJohnstonMD

How will the court's decision in ACLA vs FDA affect the future of public health? In @JAMAHealthForum, @jsross119 @reshmagar and I from @Yale_CRRIT explore the history of LDT regulation and the implications for future @US_FDA policy (1/10)