https://websites4-live-prod.ysmdevs.com/crrit/news-rss/?orgId=121706&title=Latest+News A selection of the latest research, academic, and other newsworthy developments at Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) en-us Copyright 2026 Yale School of Medicine Thu, 14 May 2026 19:06:12 Z https://news.yale.edu/2026/03/05/cost-physical-therapy-varies-widely-state-state https://news.yale.edu/2026/03/05/cost-physical-therapy-varies-widely-state-state A new Yale study examines cost variation for physical therapy across the United States. Thu, 05 Mar 2026 16:00:00 Z https://www.usnews.com/news/health-news/articles/2025-09-18/pharma-payments-might-influence-ms-drug-prescriptions-researchers-argue https://www.usnews.com/news/health-news/articles/2025-09-18/pharma-payments-might-influence-ms-drug-prescriptions-researchers-argue Nearly 4 out of 5 American neurologists prescribing multiple sclerosis (MS) drugs have received at least one payment from the pharmaceutical industry, a new study reports. Thu, 18 Sep 2025 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/fellow-focus-in-four-joshua-skydel-md/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/fellow-focus-in-four-joshua-skydel-md/ Meet clinical fellow, Joshua Skydel, MD, who aims to develop methods for using real-world data to evaluate the safety and effectiveness of disease-modifying antirheumatic drugs Tue, 16 Sep 2025 14:00:00 Z https://www.mmm-online.com/news/trump-lower-drug-prices-dtc-platforms/ https://www.mmm-online.com/news/trump-lower-drug-prices-dtc-platforms/ Reshma Ramachandran, MD, MHS, MPP, discusses the use of direct-to-consumer (DTC) platforms in pharmaceutical pricing. Fri, 05 Sep 2025 04:00:00 Z https://www.healthcaredive.com/news/ai-medical-devices-no-validation-more-recalls-jama/758998/ https://www.healthcaredive.com/news/ai-medical-devices-no-validation-more-recalls-jama/758998/ Public companies, which accounted for about half of AI-enabled devices on the market, had a higher rate of recalls and a lower rate of clinical evidence, according to a JAMA study, co-authored by Yale's Dr. Joseph Ross. Tue, 02 Sep 2025 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-postdocs-postgrads-july-2025/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-postdocs-postgrads-july-2025/ The Department of Internal Medicine is pleased to welcome the following new staff, clinical fellows, postdoctoral fellows, postdoctoral associates, and postgraduate associates who recently joined the department. Tue, 15 Jul 2025 04:00:00 Z https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html?smid=nytcore-android-share https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html?smid=nytcore-android-share Yale School of Medicine's Reshma Ramachandran, MD, MPP, MHS, discusses how expedited drug approvals by the F.D.A., with less evidence, can shift uncertainty onto doctors and patients. Tue, 08 Jul 2025 04:00:00 Z https://www.npr.org/transcripts/1255282262 https://www.npr.org/transcripts/1255282262 YSPH Associate Professor Jason Schwartz says pediatricians and other frontline health care providers will play a key role in helping rebuild trust in vaccines, which has eroded in recent years. Sun, 06 Jul 2025 04:00:00 Z https://www.biospace.com/fda/fda-conditional-pathway-not-necessary-rare-disease-experts-say-while-applauding-intent https://www.biospace.com/fda/fda-conditional-pathway-not-necessary-rare-disease-experts-say-while-applauding-intent Rare disease experts discussed a new regulatory pathway proposed for the FDA at Bio2025, an international convention considered the largest and most comprehensive event for biotechnology. YSM & YSPH Professor Joseph Ross said the pathway is likely not needed, but it may have some value. Tue, 24 Jun 2025 04:00:00 Z https://lowninstitute.org/dr-reshma-ramachandran-winner-of-the-2025-bernard-lown-award/ https://lowninstitute.org/dr-reshma-ramachandran-winner-of-the-2025-bernard-lown-award/ Yale School of Medicine's Reshma Ramachandran, MD, MPP, MHS, assistant professor of medicine (general medicine), won the 2025 Bernard Lown Award for Social Responsibility. Tue, 13 May 2025 16:00:00 Z https://www.statnews.com/2025/04/29/compounded-glp-1-drugs-patients-seek-semaglutide-alternatives-wegovy-zepbound-mounjaro/ https://www.statnews.com/2025/04/29/compounded-glp-1-drugs-patients-seek-semaglutide-alternatives-wegovy-zepbound-mounjaro/ Reshma Ramachandran, MD, assistant professor of medicine (general medicine) at Yale School of Medicine, discusses patients' use of compounded GLP-1s over expensive branded drugs. Tue, 29 Apr 2025 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/harnessing-change-through-research-reshma-ramachandran/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/harnessing-change-through-research-reshma-ramachandran/ Yale School of Medicine's Reshma Ramachandran, MD, MPP, MHS, wants to ensure that everyone has access to safe and effective medical treatments. Tue, 22 Apr 2025 12:33:00 Z https://thehill.com/newsletters/health-care/5236958-kennedy-pushes-vaccine-after-second-child-dies-of-measles/ https://thehill.com/newsletters/health-care/5236958-kennedy-pushes-vaccine-after-second-child-dies-of-measles/ Health and Human Services Director Robert F. Kennedy Jr. endorses the measles vaccine after a child dies in Texas, but YSPH Associate Professor Jason Schwartz said the message was undercut by Kennedy's continued support of questionable alternative treatments. Tue, 08 Apr 2025 04:00:00 Z https://www.post-gazette.com/news/politics-nation/2025/03/25/cdc-officials-new-york-trump-atlanta/stories/202503250078 https://www.post-gazette.com/news/politics-nation/2025/03/25/cdc-officials-new-york-trump-atlanta/stories/202503250078 The recent departure of five high-level officials from the CDC reflects a further erosion of the agency's experienced leadership, YSPH health policy researcher Jason Schwartz says. Tue, 25 Mar 2025 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-researchers-launch-openrxiv-to-secure-the-future-of-open-science/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-researchers-launch-openrxiv-to-secure-the-future-of-open-science/ Preprint server medRxiv played an essential role during the pandemic. Its founders are part of a new effort to guarantee the server’s long-term stability. Tue, 11 Mar 2025 13:15:00 Z https://www.science.org/content/article/rfk-jr-says-federal-vaccine-advisers-are-beholden-industry-evidence-does-not-support https://www.science.org/content/article/rfk-jr-says-federal-vaccine-advisers-are-beholden-industry-evidence-does-not-support YSPH Associate Professor Jason Schwartz stresses the important role of the national vaccine advisory committee in this Science news article. Fri, 07 Mar 2025 05:00:00 Z https://www.nytimes.com/2025/02/28/well/measles-outbreaks-texas-rfk-jr.html https://www.nytimes.com/2025/02/28/well/measles-outbreaks-texas-rfk-jr.html Experts answered key questions about the severity of the virus and the effectiveness of the vaccine. Fri, 28 Feb 2025 05:00:00 Z https://www.healthday.com/health-news/public-health/federal-judge-rules-fda-cdc-must-restore-health-websites-removed-under-trump-order https://www.healthday.com/health-news/public-health/federal-judge-rules-fda-cdc-must-restore-health-websites-removed-under-trump-order A federal judge has ordered the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration Thu, 13 Feb 2025 05:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-postdocs-postgrads-october-2024/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-postdocs-postgrads-october-2024/ The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postgraduate fellows, postgraduate associates, and postdoctoral associates who joined the team in September 2024. Wed, 16 Oct 2024 04:00:00 Z https://www.biospace.com/fda/5-accelerated-approvals-gone-wrong https://www.biospace.com/fda/5-accelerated-approvals-gone-wrong Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials. Mon, 14 Oct 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-fellows-postdocs-september-2024/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-fellows-postdocs-september-2024/ The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral fellows, and postdoctoral associates who joined the team in August 2024: Thu, 12 Sep 2024 04:00:00 Z https://kffhealthnews.org/news/article/supreme-court-chevron-deference-doctrine-health-care-policy-shockwaves/ https://kffhealthnews.org/news/article/supreme-court-chevron-deference-doctrine-health-care-policy-shockwaves/ A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care. YSPH Professor Dr. Joseph Ross provides insight. Mon, 01 Jul 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-crrit-cancer-drug-guidelines-fda-approvals/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-crrit-cancer-drug-guidelines-fda-approvals/ Drugs for serious or life-threatening diseases can receive expedited U.S. Food and Drug Administration (FDA) review, allowing patients to receive faster access to promising new treatments. Under the expedited review pathway of accelerated approval, drugs can be FDA-approved based on surrogate markers or proxy measures such as changes in imaging or lab tests that are “reasonably likely” to predict whether patients improve in how they feel, function, or survive. Wed, 26 Jun 2024 04:00:00 Z https://www.nature.com/articles/d41586-024-02020-5 https://www.nature.com/articles/d41586-024-02020-5 Researchers are calling on the US Food and Drug Administration (FDA) to be more transparent in how it incorporates recommendations from independent scientists on its advisory panels when it approves drugs or makes other key decisions. Thu, 13 Jun 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/fda-use-of-proxies-to-expedite-drug-approvals-not-supported-by-evidence-analysis-finds/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/fda-use-of-proxies-to-expedite-drug-approvals-not-supported-by-evidence-analysis-finds/ Surrogate markers of disease outcome aimed at speeding clinical trials are routinely accepted by the FDA for drug approvals, but most lack the requisite evidence. Tue, 28 May 2024 14:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/prices-of-expensive-diabetes-medicines-and-weight-loss-drugs-are-drastically-higher-than-production-costs/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/prices-of-expensive-diabetes-medicines-and-weight-loss-drugs-are-drastically-higher-than-production-costs/ Researchers estimated the costs to produce a range of diabetes medicines, including insulin, SGLT2 inhibitors, and GLP-1 agonists. Their findings highlight market prices that are far above those costs. Mon, 29 Apr 2024 16:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/diabetes-medication-lower-costs/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/diabetes-medication-lower-costs/ A recent study published in Journal of the American Medical Association (JAMA) Network Open found that key diabetes medicines can likely be manufactured at costs far below their current market prices. The economic evaluation, led by Yale postdoctoral associate Melissa Barber, PhD in conjunction with collaborators from Doctors Without Borders (Médecins Sans Frontières (MSF)), calculated the manufacturing costs for insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagon-like peptide 1 agonists (GLP1As) – all widely used diabetes medicines. Wed, 24 Apr 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/equity-measures-hospital-readmissions/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/equity-measures-hospital-readmissions/ A recent collaborative study conducted by Yale researchers sought to apply these methods towards developing a framework for measuring equitable readmissions to the hospital, and to identify hospitals that have equitable rates of readmission. Wed, 03 Apr 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-research-2024-american-college-cardiology/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-research-2024-american-college-cardiology/ Yale faculty and trainees will present clinical research at the upcoming American College of Cardiology Scientific Meeting. Mon, 01 Apr 2024 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-staff-faculty-postdocs-postgrad-dec2023/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-staff-faculty-postdocs-postgrad-dec2023/ The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral/postgraduate associates, and postdoctoral fellows who joined the team in November 2023. Thu, 14 Dec 2023 05:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-postdocs-postgrads-oct2023/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/welcome-new-staff-faculty-postdocs-postgrads-oct2023/ The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral/postgraduate associates, and postdoctoral/postgraduate fellows who joined the team in September 2023. Thu, 12 Oct 2023 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/phenylephrine-a-common-decongestant-is-ineffective-say-fda-advisors-its-not-alone/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/phenylephrine-a-common-decongestant-is-ineffective-say-fda-advisors-its-not-alone/ An FDA advisory committee found that an OTC decongestant, phenylephrine, works no better than a placebo at relieving congestion. Yale researchers discuss how drugs with insufficient evidence make it to market. Thu, 05 Oct 2023 21:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-open-data-access-project-reaches-milestone-in-helping-to-maximize-the-use-of-clinical-trial-data-for-research/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-open-data-access-project-reaches-milestone-in-helping-to-maximize-the-use-of-clinical-trial-data-for-research/ The Yale Open Data Access (YODA) Project, a pioneering initiative to promote open science and facilitate sharing of clinical trial research data, has reached the milestone of supporting more than 100 publications. Mon, 11 Sep 2023 16:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-mayo-clinic-cersi-earns-five-year-fda-renewal/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/yale-mayo-clinic-cersi-earns-five-year-fda-renewal/ The Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI) was recently renewed with an award of up to $50M for five years from the U.S. Food and Drug Administration (FDA). The partnership between Yale School of Medicine (YSM) and Mayo Clinic provides academic scientists the opportunity to perform regulatory science research, training, and education in collaboration with the FDA. Wed, 05 Jul 2023 04:00:00 Z https://endpts.com/the-202-under-40-your-guide-to-the-next-generation-of-biotech-leaders/ https://endpts.com/the-202-under-40-your-guide-to-the-next-generation-of-biotech-leaders/ Reshma Ramachandran, MD, MPP, MHS, named by Endpoint News, the leading pharm/biotech trade news organization, as one of the 20 under 40 "next generation" of biotech leaders! Wed, 24 May 2023 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/discoveries-and-impact-may-2023/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/discoveries-and-impact-may-2023/ Discoveries & Impact highlights select scientific discoveries across the Department of Internal Medicine... Thu, 11 May 2023 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/meet-yale-internal-medicine-reshma-ramachandran-md-mpp-mhs/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/meet-yale-internal-medicine-reshma-ramachandran-md-mpp-mhs/ Reshma Ramachandran, MD, MPP, MHS, not only believes in equitable access to healthcare and medical products but is a formidable force in advocating for it. Fri, 21 Apr 2023 04:00:00 Z https://www.npr.org/sections/health-shots/2023/03/03/1160702899/fda-enforcement-drug-approval-manufacturer-promises' https://www.npr.org/sections/health-shots/2023/03/03/1160702899/fda-enforcement-drug-approval-manufacturer-promises' Changes were expected to get folded into renewal of the Prescription Drug User Fee Act in September, but Congress passed it without any riders. That worried Dr. Reshma Ramachandran, of Yale School of Medicine, who was one of the doctors who traveled to Washington, D.C., to talk to legislators about accelerated approval updates. Fri, 03 Mar 2023 04:00:00 Z https://websites4-live-prod.ysmdevs.com/crrit/news-article/increasing-diversity-in-clinical-trials-a-qanda-with-jennifer-miller-phd/ https://websites4-live-prod.ysmdevs.com/crrit/news-article/increasing-diversity-in-clinical-trials-a-qanda-with-jennifer-miller-phd/ Jennifer Miller, PhD, associate professor of medicine (general medicine), specializes in developing and using metrics to enhance accountability and social responsibility in biomedical innovation. Tue, 28 Feb 2023 04:00:00 Z https://www.npr.org/2023/02/25/1159528580/the-fda-recently-gained-more-leverage-over-pharmaceutical-companies-will-it-use- https://www.npr.org/2023/02/25/1159528580/the-fda-recently-gained-more-leverage-over-pharmaceutical-companies-will-it-use- Reshma Ramachandran, MD, MPP, MHS, assistant professor of medicine (general medicine), talks about the new law that allows the FDA to require companies to start confirmatory studies before it grants accelerated approval. Sat, 25 Feb 2023 04:00:00 Z https://www.hcplive.com/view/1-in-10-fda-approved-drugs-miss-primary-end-point-pivotal-trial https://www.hcplive.com/view/1-in-10-fda-approved-drugs-miss-primary-end-point-pivotal-trial New data show the FDA's rationale for approving drugs with unmet efficacy end points in pivotal trials has been inconsistent since at least 2018. Wed, 15 Feb 2023 04:00:00 Z https://www.mmitnetwork.com/aishealth/spotlight-on-market-access/new-law-could-make-accelerated-approval-stricter-if-fda-enforces-it-2/#:~:text=New%20Law%20Could%20Make%20Accelerated%20Approval%20Stricter%2C%20If%20FDA%20Enforces%20It,-February%202&text=The%20FDA's%20accelerated%20approval%20pathway,that%20funds%20the%20federal%20government. https://www.mmitnetwork.com/aishealth/spotlight-on-market-access/new-law-could-make-accelerated-approval-stricter-if-fda-enforces-it-2/#:~:text=New%20Law%20Could%20Make%20Accelerated%20Approval%20Stricter%2C%20If%20FDA%20Enforces%20It,-February%202&text=The%20FDA's%20accelerated%20approval%20pathway,that%20funds%20the%20federal%20government. The FDA’s accelerated approval pathway will see major changes following December 2022. Wed, 08 Feb 2023 04:00:00 Z https://news.yale.edu/2023/01/19/loophole-enables-fda-approval-unsafe-medical-devices-yale-study-finds https://news.yale.edu/2023/01/19/loophole-enables-fda-approval-unsafe-medical-devices-yale-study-finds New Yale research finds that many medical devices subject to recall had received FDA approval based, in part, on the products’ similarities to earlier devices which had also been subject to recalls, including an intra-aortic balloon pump used in patients hospitalized for heart failure. Thu, 19 Jan 2023 04:00:00 Z https://www.biospace.com/article/gsk-s-multiple-myeloma-drug-blenrep-misses-mark-in-confirmatory-trial/ https://www.biospace.com/article/gsk-s-multiple-myeloma-drug-blenrep-misses-mark-in-confirmatory-trial/ GlaxoSmithKline’s Blenrep (belantamab mafodotin) missed the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), the company announced Monday, possibly putting the drug’s continued approval at risk. Mon, 07 Nov 2022 04:00:00 Z https://www.statnews.com/pharmalot/2022/11/04/antibiotics-antimicrobials-pasteur-netflix-subscription/ https://www.statnews.com/pharmalot/2022/11/04/antibiotics-antimicrobials-pasteur-netflix-subscription/ Amid mounting concern over antibiotic resistance, a coalition of academics and advocacy groups is urging Congress not to pass legislation to reward drug companies for developing new treatments, because they argue the bill fails to require acceptable clinical trial standards and is tantamount to a giveaway to the pharmaceutical industry. Fri, 04 Nov 2022 04:00:00 Z https://www.medpagetoday.com/special-reports/features/101351 https://www.medpagetoday.com/special-reports/features/101351 The FDA is in need of structural and cultural changes to bring the agency in line with its original mission of acting as an independent government regulator of the food and drug industries, according to a panel of experts. Fri, 21 Oct 2022 04:00:00 Z https://www.politico.com/news/2022/10/16/pregnancy-drug-fda-expediting-makena-00061946 https://www.politico.com/news/2022/10/16/pregnancy-drug-fda-expediting-makena-00061946 The years-long effort to yank the drug's approval offers a case study of the agency's accelerated approval program, which green-lit Makena in 2011. Sun, 16 Oct 2022 04:00:00 Z https://www.raps.org/news-and-articles/news-articles/2022/10/study-highlights-lack-of-transparency-in-fdas-regu https://www.raps.org/news-and-articles/news-articles/2022/10/study-highlights-lack-of-transparency-in-fdas-regu Only about one-third of the US Food and Drug Administration’s (FDA) regulatory safety actions were supported by published studies and none were corroborated by public assessments from the Sentinel Initiative, according to a study of the agency’s adverse event reporting system. Wed, 12 Oct 2022 04:00:00 Z https://news.bloombergtax.com/pharma-and-life-sciences/biogens-next-alzheimer-drug-feeds-push-for-fda-approval-revamp?context=search&index=7 https://news.bloombergtax.com/pharma-and-life-sciences/biogens-next-alzheimer-drug-feeds-push-for-fda-approval-revamp?context=search&index=7 Promising trial results on Eisai Co. and Biogen Inc.‘s Alzheimer’s drug don’t discount the need for changes to the fast-track approval pathway the FDA is using to review the product, doctors and health policy analysts say. Fri, 30 Sep 2022 04:00:00 Z https://www.nytimes.com/2022/09/15/health/fda-drug-industry-fees.html?action=click&module=Well&pgtype=Homepage&section=Health https://www.nytimes.com/2022/09/15/health/fda-drug-industry-fees.html?action=click&module=Well&pgtype=Homepage&section=Health Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billion this year. But the F.D.A. is not at the table with members of Congress or with White House officials. Instead, it’s in dozens of meetings with representatives of the giant pharmaceutical companies whose products the agency regulates. Thu, 15 Sep 2022 04:00:00 Z