Reshma Ramachandran, MD, MPP, MHS
Titles
- Assistant Professor of Medicine (General Medicine)
Education & Training
- MHSYale School of Medicine, National Clinician Scholars Program (2022)
- FellowshipYale University School of Medicine (2022)
- ResidencyKaiser Permanente Los Angeles Medical Center (2020)
- MPPHarvard Kennedy School, International Trade and Finance (2015)
- MDAlpert Medical School at Brown University (2015)
- ScBBrown University, Physics (2009)
Additional Information
Publications
- Patel NG, Ramachandran R, Ross JS. Changes in pharmaceutical industry payments to physicians after New Jersey's 2018 restriction. Health Aff Sch 2025, 4: qxaf254. PMID: 41536639, DOI: 10.1093/haschl/qxaf254.
- Doernberg H, Wallach J, Jeffery M, Mooghali M, Ramachandran R, Ross J. Postmarket Drug Safety−Related Actions Before and After the US Food and Drug Administration Amendments Act. JAMA Internal Medicine 2025, 186 PMID: 41359349, PMCID: PMC12687201, DOI: 10.1001/jamainternmed.2025.6566.
- Wallach J, Ross J, Ramachandran R. Enhancing FDA Drug-Safety Surveillance — Beyond Releasing Daily Adverse-Event Data. The New England Journal Of Medicine 2025, 393: 2284-2286. PMID: 41358589, DOI: 10.1056/nejmp2513460.
- Dhawan R, Shay D, Leland A, Ramachandran R, Ross J, Wallach J. Venture Capital Investments by Academic Medical Centers in Health Care Companies. JAMA Internal Medicine 2025, 186 PMID: 41182783, PMCID: PMC12584060, DOI: 10.1001/jamainternmed.2025.5480.
- Godoy C, Ramachandran R, Sapre P, Ross J. Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical Trials 2025, 17407745251376620. PMID: 41090443, DOI: 10.1177/17407745251376620.
- Mitchell A, Lam M, Carlin C, Tyan K, Mooghali M, Zakaria Z, Ramachandran R, Jung J. Use of low-value cancer care after practice acquisition by private equity. JCO Oncology Practice 2025, 21: 59-59. DOI: 10.1200/op.2025.21.10_suppl.59.
- Jiang T, Ramachandran R, Vokinger K, Ross J. Therapeutic benefit of the most expensive drugs covered by Medicare and Medicaid. Journal Of Pharmaceutical Policy And Practice 2025, 18: 2564405. PMID: 41050428, PMCID: PMC12490368, DOI: 10.1080/20523211.2025.2564405.
- Lynch H, Lee S, Herder M, Ross J, Ramachandran R. Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval. Health Affairs Scholar 2025, 3: qxaf183. PMID: 41245507, PMCID: PMC12617412, DOI: 10.1093/haschl/qxaf183.
- Mooghali M, Ramachandran R, Mohammad A, Mitchell A. Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. Journal Of The National Cancer Institute 2025, djaf241. PMID: 40855611, DOI: 10.1093/jnci/djaf241.
- Sayed A, Gupta R, Ramachandran R, Rivero-de-Aguilar A, Ross J. Industry payments to US neurologists related to multiple sclerosis drugs and prescribing (2015–2019): a retrospective cohort study. BMJ Open 2025, 15: e095952. PMID: 40858330, PMCID: PMC12406943, DOI: 10.1136/bmjopen-2024-095952.
- Ziaks T, Schwartz J, Ross J, Ramachandran R. Reforming the Prescription Drug User Fee Program. The New England Journal Of Medicine 2025, 393: 734-736. PMID: 40834320, DOI: 10.1056/nejmp2507648.
- Kadakia K, Dhruva S, Ross J, Burke J, Johnston J, Ramachandran R, Krumholz H, Rathi V. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Internal Medicine 2025, 185: 996-1004. PMID: 40587167, PMCID: PMC12210143, DOI: 10.1001/jamainternmed.2025.2235.
- Jiang T, Ramachandran R, Skydel J. Regulatory change could improve biosimilar access in the US. The BMJ 2025, 390: e084860. PMID: 40730379, DOI: 10.1136/bmj-2025-084860.
- Chen A, Liang Y, Lipska K, Ross J, Ramachandran R. Exclusion of Older Adults from Obesity Treatment Pivotal Trials of GLP-1RAs and GIP/GLP-1RAs. Journal Of General Internal Medicine 2025, 1-3. PMID: 40728804, DOI: 10.1007/s11606-025-09769-z.
- Miller J, Pelletiers W, Gross C, Mello M, Ramachandran R, Schwartz J, Suttiratana S, Varma T, Ross J. Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time. JCO Oncology Practice 2025, op2400563. PMID: 40493876, PMCID: PMC12360498, DOI: 10.1200/op-24-00563.
- Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed TestsKadakia K, Ross J, Ramachandran R. Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests. JAMA Health Forum 2025, 6: e252233. PMID: 40540283, DOI: 10.1001/jamahealthforum.2025.2233.
- Ding Y, Fu M, Ramachandran R, Shi L, Ross J, Guan X. Regulatory Review Time of Vaccine Approvals in China Between 2005 and 2024. JAMA Network Open 2025, 8: e2518255. PMID: 40587134, PMCID: PMC12210079, DOI: 10.1001/jamanetworkopen.2025.18255.
- Mooghali M, Ramachandran R, Mohammad A, Mitchell A. Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. Journal Of Clinical Oncology 2025, 43: 11029-11029. DOI: 10.1200/jco.2025.43.16_suppl.11029.
- Jiang T, Ramachandran R, Lipska K, Ross J. Insulin rationing in states with and without insulin copay caps: a cross-sectional study. Health Affairs Scholar 2025, 3: qxaf100. PMID: 40406499, PMCID: PMC12097487, DOI: 10.1093/haschl/qxaf100.
- Zhang A, Chaudhry N, Ramachandran R, Ross J, Schwartz J. FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022. The Journal Of Law, Medicine & Ethics 2025, 53: 1-8. PMID: 40195284, DOI: 10.1017/jme.2025.53.
- Janda G, Moneer O, Mooghali M, Ramachandran R, Wallach J, Dhruva S, Ross J. Research Derived From Medicare’s Coverage With Evidence Development Program. JAMA Network Open 2025, 8: e255077. PMID: 40232723, PMCID: PMC12000966, DOI: 10.1001/jamanetworkopen.2025.5077.
- Mooghali M, Moneer O, Janda G, Ross J, Dhruva S, Ramachandran R. Characterization of studies considered and required under Medicare’s coverage with evidence development program. Clinical Trials 2025, 22: 619-625. PMID: 39921418, DOI: 10.1177/17407745251313979.
- Chetty A, Chillakanti M, Ramachandran R, Ross J, Chen A. Online Advertising of Compounded Glucagon-Like Peptide-1 Receptor Agonists. JAMA Health Forum 2025, 6: e245018. PMID: 39820389, PMCID: PMC11742527, DOI: 10.1001/jamahealthforum.2024.5018.
- Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. Assessing Medicare’s Coverage With Evidence Development Program. Health Affairs 2025, 44: 32-39. PMID: 39761464, DOI: 10.1377/hlthaff.2024.00814.
- Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA: The Journal Of The American Medical Association 2024, 332: 1943-1945. PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.
- Moneer O, Mooghali M, Moosa K, Ramachandran R, Ross J, Dhruva S. Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications. Health Affairs 2024, 43: 1712-1718. PMID: 39626147, DOI: 10.1377/hlthaff.2024.00182.
- Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.
- Kadakia K, Ross J, Ramachandran R. At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? JAMA Internal Medicine 2024, 184: 1153-1155. PMID: 39133501, DOI: 10.1001/jamainternmed.2024.2883.
- Janda G, Jeffery M, Ramachandran R, Ross J, Wallach J. Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study. BMC Medical Research Methodology 2024, 24: 187. PMID: 39198727, PMCID: PMC11351457, DOI: 10.1186/s12874-024-02307-1.
- Wallach J, Ramachandran R, Ross J. Surrogate Markers and Clinical Outcomes—Reply. JAMA: The Journal Of The American Medical Association 2024, 332: 936-937. PMID: 39167385, DOI: 10.1001/jama.2024.14279.
- Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.
- Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.
- Axson S, Ramachandran R, Lisenby A, Giordano N. Consent Form Reporting on ClinicalTrials.Gov, 2013-2023. JAMA Network Open 2024, 7: e2418895. PMID: 38904965, PMCID: PMC11193120, DOI: 10.1001/jamanetworkopen.2024.18895.
- Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.
- Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. HPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023. Value In Health 2024, 27: s208. DOI: 10.1016/j.jval.2024.03.1151.
- Roy V, Ross J, Ramachandran R. A Public Option for Clinical Trials? Lessons from Convalescent Plasma. The Journal Of Law, Medicine & Ethics 2024, 52: 98-100. PMID: 38818610, DOI: 10.1017/jme.2024.57.
- Gupta R, Ramachandran R, Ross J. Tackling the excesses of pharmaceutical marketing and promotion. The BMJ 2024, 385: e076797. PMID: 38772671, DOI: 10.1136/bmj-2023-076797.
- Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA: The Journal Of The American Medical Association 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.
- Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.
- Agrawal S, Ross J, Ramachandran R. Implications for Public Health Regulation if Chevron Deference Is Overturned. JAMA: The Journal Of The American Medical Association 2024, 331: 1443-1444. PMID: 38506706, DOI: 10.1001/jama.2024.3654.
- Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication ApprovalsMooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.
- Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.
- Nagel K, Ramachandran R, Lipska K. Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications. Diabetes Care 2024, 47: 1246-1256. PMID: 38536964, PMCID: PMC11272967, DOI: 10.2337/dci23-0042.
- Qureshi O, Ramachandran R, Ross J. Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016–2019 data. Journal Of Pharmaceutical Policy And Practice 2024, 17: 2312374. PMID: 38434725, PMCID: PMC10906125, DOI: 10.1080/20523211.2024.2312374.
- Patel N, Mohammad A, Ross J, Ramachandran R. US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion. The BMJ 2024, 384: e076138. PMID: 38383007, DOI: 10.1136/bmj-2023-076138.
- Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA: The Journal Of The American Medical Association 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.
- Wallach J, Gautam A, Ramachandran R, Ross J. Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies. The BMJ 2023, 383: e077166. PMID: 38123175, PMCID: PMC11957479, DOI: 10.1136/bmj-2023-077166.
- Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.
- Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.
- Bhat S, Ross J, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Internal Medicine 2023, 183: 1164-1166. PMID: 37603342, PMCID: PMC10442781, DOI: 10.1001/jamainternmed.2023.2842.
- Lu A, Ji R, Ge A, Ross J, Ramachandran R, Redberg R, Dhruva S. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA: The Journal Of The American Medical Association 2023, 330: 1094-1096. PMID: 37589985, PMCID: PMC10436180, DOI: 10.1001/jama.2023.14414.
- Wong A, Mooghali M, Ramachandran R, Ross J, Wallach J. Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics. JAMA Network Open 2023, 6: e2331753. PMID: 37651145, PMCID: PMC10472182, DOI: 10.1001/jamanetworkopen.2023.31753.
- Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.
- Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R. Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum 2023, 4: e231313. PMID: 37294583, DOI: 10.1001/jamahealthforum.2023.1313.
- Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.
- Kadakia K, Rathi V, Ramachandran R, Johnston J, Ross J, Dhruva S. Challenges and solutions to advancing health equity with medical devices. Nature Biotechnology 2023, 41: 607-609. PMID: 37037905, DOI: 10.1038/s41587-023-01746-3.
- Ross J, Berg K, Ramachandran R. Ensuring Public Trust in an Empowered FDA. The New England Journal Of Medicine 2023, 388: 1249-1251. PMID: 37017494, DOI: 10.1056/nejmp2300438.
- Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.
- Mooghali M, Glick L, Ramachandran R, Ross J. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study. BMJ Open 2023, 13: e069115. PMID: 36690402, PMCID: PMC9872463, DOI: 10.1136/bmjopen-2022-069115.
- Ramachandran R. If Left Unchecked: Lessons Learned from Unfettered U.S. Government Support of the NIH-Moderna Vaccine. The Journal Of Law, Medicine & Ethics 2023, 51: 41-45. PMID: 38433676, PMCID: PMC10911987, DOI: 10.1017/jme.2023.155.
- Ramachandran R. Evidence and opportunity costs of lifestyle interventions in clinical medicine. BMJ Medicine 2022, 1: e000336. PMID: 36936571, PMCID: PMC9951366, DOI: 10.1136/bmjmed-2022-000336.
Departments and Programs
Titles
- Assistant Professor of Medicine (General Medicine)
Education & Training
- MHSYale School of Medicine, National Clinician Scholars Program (2022)
- FellowshipYale University School of Medicine (2022)
- ResidencyKaiser Permanente Los Angeles Medical Center (2020)
- MPPHarvard Kennedy School, International Trade and Finance (2015)
- MDAlpert Medical School at Brown University (2015)
- ScBBrown University, Physics (2009)
Additional Information
Publications
- Patel NG, Ramachandran R, Ross JS. Changes in pharmaceutical industry payments to physicians after New Jersey's 2018 restriction. Health Aff Sch 2025, 4: qxaf254. PMID: 41536639, DOI: 10.1093/haschl/qxaf254.
- Doernberg H, Wallach J, Jeffery M, Mooghali M, Ramachandran R, Ross J. Postmarket Drug Safety−Related Actions Before and After the US Food and Drug Administration Amendments Act. JAMA Internal Medicine 2025, 186 PMID: 41359349, PMCID: PMC12687201, DOI: 10.1001/jamainternmed.2025.6566.
- Wallach J, Ross J, Ramachandran R. Enhancing FDA Drug-Safety Surveillance — Beyond Releasing Daily Adverse-Event Data. The New England Journal Of Medicine 2025, 393: 2284-2286. PMID: 41358589, DOI: 10.1056/nejmp2513460.
- Dhawan R, Shay D, Leland A, Ramachandran R, Ross J, Wallach J. Venture Capital Investments by Academic Medical Centers in Health Care Companies. JAMA Internal Medicine 2025, 186 PMID: 41182783, PMCID: PMC12584060, DOI: 10.1001/jamainternmed.2025.5480.
- Godoy C, Ramachandran R, Sapre P, Ross J. Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical Trials 2025, 17407745251376620. PMID: 41090443, DOI: 10.1177/17407745251376620.
- Mitchell A, Lam M, Carlin C, Tyan K, Mooghali M, Zakaria Z, Ramachandran R, Jung J. Use of low-value cancer care after practice acquisition by private equity. JCO Oncology Practice 2025, 21: 59-59. DOI: 10.1200/op.2025.21.10_suppl.59.
- Jiang T, Ramachandran R, Vokinger K, Ross J. Therapeutic benefit of the most expensive drugs covered by Medicare and Medicaid. Journal Of Pharmaceutical Policy And Practice 2025, 18: 2564405. PMID: 41050428, PMCID: PMC12490368, DOI: 10.1080/20523211.2025.2564405.
- Lynch H, Lee S, Herder M, Ross J, Ramachandran R. Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval. Health Affairs Scholar 2025, 3: qxaf183. PMID: 41245507, PMCID: PMC12617412, DOI: 10.1093/haschl/qxaf183.
- Mooghali M, Ramachandran R, Mohammad A, Mitchell A. Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. Journal Of The National Cancer Institute 2025, djaf241. PMID: 40855611, DOI: 10.1093/jnci/djaf241.
- Sayed A, Gupta R, Ramachandran R, Rivero-de-Aguilar A, Ross J. Industry payments to US neurologists related to multiple sclerosis drugs and prescribing (2015–2019): a retrospective cohort study. BMJ Open 2025, 15: e095952. PMID: 40858330, PMCID: PMC12406943, DOI: 10.1136/bmjopen-2024-095952.
- Ziaks T, Schwartz J, Ross J, Ramachandran R. Reforming the Prescription Drug User Fee Program. The New England Journal Of Medicine 2025, 393: 734-736. PMID: 40834320, DOI: 10.1056/nejmp2507648.
- Kadakia K, Dhruva S, Ross J, Burke J, Johnston J, Ramachandran R, Krumholz H, Rathi V. FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program. JAMA Internal Medicine 2025, 185: 996-1004. PMID: 40587167, PMCID: PMC12210143, DOI: 10.1001/jamainternmed.2025.2235.
- Jiang T, Ramachandran R, Skydel J. Regulatory change could improve biosimilar access in the US. The BMJ 2025, 390: e084860. PMID: 40730379, DOI: 10.1136/bmj-2025-084860.
- Chen A, Liang Y, Lipska K, Ross J, Ramachandran R. Exclusion of Older Adults from Obesity Treatment Pivotal Trials of GLP-1RAs and GIP/GLP-1RAs. Journal Of General Internal Medicine 2025, 1-3. PMID: 40728804, DOI: 10.1007/s11606-025-09769-z.
- Miller J, Pelletiers W, Gross C, Mello M, Ramachandran R, Schwartz J, Suttiratana S, Varma T, Ross J. Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time. JCO Oncology Practice 2025, op2400563. PMID: 40493876, PMCID: PMC12360498, DOI: 10.1200/op-24-00563.
- Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed TestsKadakia K, Ross J, Ramachandran R. Public Health Implications of Legal Challenges to the FDA’s Regulation of Laboratory-Developed Tests. JAMA Health Forum 2025, 6: e252233. PMID: 40540283, DOI: 10.1001/jamahealthforum.2025.2233.
- Ding Y, Fu M, Ramachandran R, Shi L, Ross J, Guan X. Regulatory Review Time of Vaccine Approvals in China Between 2005 and 2024. JAMA Network Open 2025, 8: e2518255. PMID: 40587134, PMCID: PMC12210079, DOI: 10.1001/jamanetworkopen.2025.18255.
- Mooghali M, Ramachandran R, Mohammad A, Mitchell A. Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials. Journal Of Clinical Oncology 2025, 43: 11029-11029. DOI: 10.1200/jco.2025.43.16_suppl.11029.
- Jiang T, Ramachandran R, Lipska K, Ross J. Insulin rationing in states with and without insulin copay caps: a cross-sectional study. Health Affairs Scholar 2025, 3: qxaf100. PMID: 40406499, PMCID: PMC12097487, DOI: 10.1093/haschl/qxaf100.
- Zhang A, Chaudhry N, Ramachandran R, Ross J, Schwartz J. FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022. The Journal Of Law, Medicine & Ethics 2025, 53: 1-8. PMID: 40195284, DOI: 10.1017/jme.2025.53.
- Janda G, Moneer O, Mooghali M, Ramachandran R, Wallach J, Dhruva S, Ross J. Research Derived From Medicare’s Coverage With Evidence Development Program. JAMA Network Open 2025, 8: e255077. PMID: 40232723, PMCID: PMC12000966, DOI: 10.1001/jamanetworkopen.2025.5077.
- Mooghali M, Moneer O, Janda G, Ross J, Dhruva S, Ramachandran R. Characterization of studies considered and required under Medicare’s coverage with evidence development program. Clinical Trials 2025, 22: 619-625. PMID: 39921418, DOI: 10.1177/17407745251313979.
- Chetty A, Chillakanti M, Ramachandran R, Ross J, Chen A. Online Advertising of Compounded Glucagon-Like Peptide-1 Receptor Agonists. JAMA Health Forum 2025, 6: e245018. PMID: 39820389, PMCID: PMC11742527, DOI: 10.1001/jamahealthforum.2024.5018.
- Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. Assessing Medicare’s Coverage With Evidence Development Program. Health Affairs 2025, 44: 32-39. PMID: 39761464, DOI: 10.1377/hlthaff.2024.00814.
- Mooghali M, Dhruva S, Ross J, Ramachandran R. Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program. JAMA: The Journal Of The American Medical Association 2024, 332: 1943-1945. PMID: 39535767, PMCID: PMC11561719, DOI: 10.1001/jama.2024.20493.
- Moneer O, Mooghali M, Moosa K, Ramachandran R, Ross J, Dhruva S. Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications. Health Affairs 2024, 43: 1712-1718. PMID: 39626147, DOI: 10.1377/hlthaff.2024.00182.
- Chaudhry N, Zhang A, Schwartz J, Ramachandran R, Ross J. Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021. JAMA Network Open 2024, 7: e2436789. PMID: 39352702, PMCID: PMC11445682, DOI: 10.1001/jamanetworkopen.2024.36789.
- Kadakia K, Ross J, Ramachandran R. At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? JAMA Internal Medicine 2024, 184: 1153-1155. PMID: 39133501, DOI: 10.1001/jamainternmed.2024.2883.
- Janda G, Jeffery M, Ramachandran R, Ross J, Wallach J. Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study. BMC Medical Research Methodology 2024, 24: 187. PMID: 39198727, PMCID: PMC11351457, DOI: 10.1186/s12874-024-02307-1.
- Wallach J, Ramachandran R, Ross J. Surrogate Markers and Clinical Outcomes—Reply. JAMA: The Journal Of The American Medical Association 2024, 332: 936-937. PMID: 39167385, DOI: 10.1001/jama.2024.14279.
- Mooghali M, Wallach J, Ross J, Ramachandran R. Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies. JAMA Network Open 2024, 7: e2430486. PMID: 39190303, PMCID: PMC11350476, DOI: 10.1001/jamanetworkopen.2024.30486.
- Miller J, Pelletiers W, Suttiratana S, Mensah M, Schwartz J, Ramachandran R, Gross C, Ross J. Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies. BMJ Medicine 2024, 3: e000920. PMID: 39175919, PMCID: PMC11340651, DOI: 10.1136/bmjmed-2024-000920.
- Axson S, Ramachandran R, Lisenby A, Giordano N. Consent Form Reporting on ClinicalTrials.Gov, 2013-2023. JAMA Network Open 2024, 7: e2418895. PMID: 38904965, PMCID: PMC11193120, DOI: 10.1001/jamanetworkopen.2024.18895.
- Mooghali M, Moneer O, Janda G, Dhruva S, Ross J, Ramachandran R. HPR109 Evaluation of Evidence Informing Medicare’s Coverage With Evidence Development Decision Updates. Value In Health 2024, 27: s214. DOI: 10.1016/j.jval.2024.03.1178.
- Mooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. HPR82 Assessment of Supporting Evidence and Postmarketing Requirements for Therapeutic Indications With Real-Time Oncology Drug Review, 2018-2023. Value In Health 2024, 27: s208. DOI: 10.1016/j.jval.2024.03.1151.
- Roy V, Ross J, Ramachandran R. A Public Option for Clinical Trials? Lessons from Convalescent Plasma. The Journal Of Law, Medicine & Ethics 2024, 52: 98-100. PMID: 38818610, DOI: 10.1017/jme.2024.57.
- Gupta R, Ramachandran R, Ross J. Tackling the excesses of pharmaceutical marketing and promotion. The BMJ 2024, 385: e076797. PMID: 38772671, DOI: 10.1136/bmj-2023-076797.
- Wallach J, Yoon S, Doernberg H, Glick L, Ciani O, Taylor R, Mooghali M, Ramachandran R, Ross J. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA: The Journal Of The American Medical Association 2024, 331: 1646-1654. PMID: 38648042, PMCID: PMC11036312, DOI: 10.1001/jama.2024.4175.
- Lu A, Ji R, Magee M, Ross J, Ramachandran R, Redberg R, Dhruva S. Funding of evidence included within public comments submitted to inform Medicare national coverage determinations. Health Affairs Scholar 2024, 2: qxae064. PMID: 38919964, PMCID: PMC11196998, DOI: 10.1093/haschl/qxae064.
- Agrawal S, Ross J, Ramachandran R. Implications for Public Health Regulation if Chevron Deference Is Overturned. JAMA: The Journal Of The American Medical Association 2024, 331: 1443-1444. PMID: 38506706, DOI: 10.1001/jama.2024.3654.
- Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication ApprovalsMooghali M, Mohammad A, Wallach J, Mitchell A, Ross J, Ramachandran R. Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals. JAMA Network Open 2024, 7: e249233. PMID: 38691363, PMCID: PMC11063797, DOI: 10.1001/jamanetworkopen.2024.9233.
- Mooghali M, Mitchell A, Skydel J, Ross J, Wallach J, Ramachandran R. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study. BMJ Medicine 2024, 3: e000802. PMID: 38596814, PMCID: PMC11002412, DOI: 10.1136/bmjmed-2023-000802.
- Nagel K, Ramachandran R, Lipska K. Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications. Diabetes Care 2024, 47: 1246-1256. PMID: 38536964, PMCID: PMC11272967, DOI: 10.2337/dci23-0042.
- Qureshi O, Ramachandran R, Ross J. Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016–2019 data. Journal Of Pharmaceutical Policy And Practice 2024, 17: 2312374. PMID: 38434725, PMCID: PMC10906125, DOI: 10.1080/20523211.2024.2312374.
- Patel N, Mohammad A, Ross J, Ramachandran R. US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion. The BMJ 2024, 384: e076138. PMID: 38383007, DOI: 10.1136/bmj-2023-076138.
- Wong A, Miller J, Mooghali M, Ramachandran R, Ross J, Wallach J. Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics. JAMA: The Journal Of The American Medical Association 2023, 330: 2392-2394. PMID: 38079163, PMCID: PMC10714278, DOI: 10.1001/jama.2023.21958.
- Wallach J, Gautam A, Ramachandran R, Ross J. Association of health benefits and harms of Christmas dessert ingredients in recipes from The Great British Bake Off: umbrella review of umbrella reviews of meta-analyses of observational studies. The BMJ 2023, 383: e077166. PMID: 38123175, PMCID: PMC11957479, DOI: 10.1136/bmj-2023-077166.
- Skydel J, Ramachandran R, Suttiratana S, Ross J, Burns C, Wallach J. Geographic and Demographic Representation in Industry-Sponsored, US-Based Clinical Trials of Systemic Lupus Erythematosus Therapies. The Journal Of Rheumatology 2023, 51: jrheum.2023-0920. PMID: 38101910, PMCID: PMC10922605, DOI: 10.3899/jrheum.2023-0920.
- Janda G, Wallach J, Dhodapkar M, Ramachandran R, Ross J. Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics. JAMA Internal Medicine 2023, 183: 1271-1273. PMID: 37782514, PMCID: PMC10546285, DOI: 10.1001/jamainternmed.2023.4073.
- Bhat S, Ross J, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Internal Medicine 2023, 183: 1164-1166. PMID: 37603342, PMCID: PMC10442781, DOI: 10.1001/jamainternmed.2023.2842.
- Lu A, Ji R, Ge A, Ross J, Ramachandran R, Redberg R, Dhruva S. Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices. JAMA: The Journal Of The American Medical Association 2023, 330: 1094-1096. PMID: 37589985, PMCID: PMC10436180, DOI: 10.1001/jama.2023.14414.
- Wong A, Mooghali M, Ramachandran R, Ross J, Wallach J. Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics. JAMA Network Open 2023, 6: e2331753. PMID: 37651145, PMCID: PMC10472182, DOI: 10.1001/jamanetworkopen.2023.31753.
- Johnston J, Ross J, Ramachandran R. Approval of Drugs With Unmet Trial End Points—In Reply. JAMA Internal Medicine 2023, 183: 889-890. PMID: 37307009, DOI: 10.1001/jamainternmed.2023.2240.
- Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R. Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum 2023, 4: e231313. PMID: 37294583, DOI: 10.1001/jamahealthforum.2023.1313.
- Dhodapkar M, Ross J, Ramachandran R. US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019. JAMA Network Open 2023, 6: e2318889. PMID: 37358857, PMCID: PMC10293905, DOI: 10.1001/jamanetworkopen.2023.18889.
- Kadakia K, Rathi V, Ramachandran R, Johnston J, Ross J, Dhruva S. Challenges and solutions to advancing health equity with medical devices. Nature Biotechnology 2023, 41: 607-609. PMID: 37037905, DOI: 10.1038/s41587-023-01746-3.
- Ross J, Berg K, Ramachandran R. Ensuring Public Trust in an Empowered FDA. The New England Journal Of Medicine 2023, 388: 1249-1251. PMID: 37017494, DOI: 10.1056/nejmp2300438.
- Johnston J, Ross J, Ramachandran R. US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021. JAMA Internal Medicine 2023, 183: 376-380. PMID: 36780148, PMCID: PMC9926353, DOI: 10.1001/jamainternmed.2022.6444.
- Mooghali M, Glick L, Ramachandran R, Ross J. Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study. BMJ Open 2023, 13: e069115. PMID: 36690402, PMCID: PMC9872463, DOI: 10.1136/bmjopen-2022-069115.
- Ramachandran R. If Left Unchecked: Lessons Learned from Unfettered U.S. Government Support of the NIH-Moderna Vaccine. The Journal Of Law, Medicine & Ethics 2023, 51: 41-45. PMID: 38433676, PMCID: PMC10911987, DOI: 10.1017/jme.2023.155.
- Ramachandran R. Evidence and opportunity costs of lifestyle interventions in clinical medicine. BMJ Medicine 2022, 1: e000336. PMID: 36936571, PMCID: PMC9951366, DOI: 10.1136/bmjmed-2022-000336.
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