2024
Perspectives, Viewpoints, and Editorials
- Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters (11/19/24)
- Enhancing Medical Device Postmarketing Safety Surveillance—The Case of Inferior Vena Cava Filters (11/06/24)
- Understanding Drug Supply Shortages in the US and Canada (10/31/24)
- Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process (10/08/24)
- Integrating Equity into Licensing Agreements For Taxpayer-Funded Technologies-Health Affairs Forefront (12/19/24)
- Enhancing Medical Device Postmarketing Safety Surveillance—The Case of Inferior Vena Cava Filters- JAMA (11/06/24)
- Understanding Drug Supply Shortages in the US and Canada- JAMA (10/31/24)
- Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process-Annals of Internal Medicine (10/8/24)
- How A Recent Supreme Court Decision May Have Already Hamstrung RFK Jr.'s Big Plans- Huffpost (11/30/24)
- Will RFK Jr Increase Access to Weed and Psychedelics?-Oncology News (11/26/24)
- 'Very reductive': Experts warn against major HHS changes coming from Trump's nominee- RawStory (11/25/24)
- Intercept is denied full FDA approval for Ocaliva, but claims it will keep drug on market- Endpoint News (11/12/24)
- FDA Urged to Levy Fines for Delayed Confirmatory Trials in Oncology and Beyond-Oncology News Central (10/30/24)
- Yale experts weigh in on Harris’ Medicare expansion plan- Yale Daily News (10/28/24)
- 5 Accelerated Approvals Gone Wrong- BioSpace (10/14/24)
- Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries- New York Times (10/7/24)
- Most cardiovascular devices with serious safety recalls aren’t tested in patients- STAT News (9/26/24)
- [U.S. Senate Roundtable Conversation] Sanders to Announce New Information on the Production and Pricing of Blockbuster Diabetes and Weight-Loss Drugs Ozempic and Wegovy at Expert Discussion-Bernie Sanders U.S. Senator for Vermont.gov (9/17/24)
- Healthcare professionals back NICE decision to reject ‘cost ineffective’ Alzheimer’s treatment on cash-strapped NHS budget, research finds- Pharmiweb (9/09/24)
- Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study-BMC Medical Research Methodology (8/28/24)
- Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies-JAMA Network Open (8/27/24)
- Prices of common medications are being lowered—what you can expect-KCBS Radio (8/15/24)
- At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation? -Published in JAMA Internal Medicine (8/12/24)
- Surrogate End Points in Trials—SPIRIT and CONSORT Extensions-JAMA (8/5/24)
- Lessons from the FDA for AI- AI Institute Now (8/01/24)
- The Fight to Reclaim Technical Expertise Amid the Fall of Chevron Deference-AI Now (8/01/24)
- To get a fair deal on Wegovy, buying Novo Nordisk might not be Medicare's worst option- STAT News (7/23/24)
- Health Care Is About to Get Even More Litigious- Bloomberg (7/12/24)
- ‘It’s astronomical’: AbbVie led the way in paying doctors to pitch its drugs last year- MM+M (7/12/24)
- Environmentalists, Public Health Advocates Worry about Ability to Regulate Industry after Supreme Court’s Decision Overturning Chevron- KQED (7/11/24)
- AbbVie dramatically outspent its pharma company rivals in 2023 to promote its drugs to doctors- STAT News (7/05/2024)
- Chevron doctrine ruling a “gut-punch’ for US health and environment-experts- The Guardian (7/06/24)
- How the Supreme Court has roiled U.S. health-care agencies- The Washington Post (7/02/24)
- How controversial was the decision by FDA’s Peter Marks to approve Sarepta’s gene therapy? Check its footnotes- STAT News (7/02/24)
- Supreme Court Imperils an Array of Federal Rules- The New York Times (6/28/24)
- The Justices just shackled Biden and every future president-and created new messes for Congress to solve- Politico (6/28/24)
- The Most Important Supreme Court Case You’ve Probably Never Heard Of- PJ Media (6/25/24)
- Surrogate Markers Used for Many New Drug Approvals Lack Follow-Up Outcomes Data: Study- Medscape (5/17/24)
- Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review ...- JAMA Network Open (5/01/24)
- Prices of Expensive Diabetes Medicines and Weight-loss Drugs Are Drastically Higher Than Production Costs- Yale School of Medicine (4/29/24)
- Diabetes Medication Can Be Manufactured at Lower Cost, New Study Says-Yale School of Medicine (4/24/24)
- Graft much? Doctors received $12 billion from drug, device makers between 2013-2022- Science Blog (3/28/24)
- $5 Ozempic? New study sparks calls for Novo Nordisk to cut prices- Becker’s Hospital Review (3/28/24)
- Heckmann and Wong Receive R01 award from National Institute of Mental Health for ...- Yale School of Medicine (3/26/24)
- Sustainable Price Estimates for Diabetes Medicines Revealed - Mirage News (3/28/24)
- Lessons From Insulin: Policy Prescriptions for Affordable Diabetes and Obesity Medications- American Diabetes Association (3/27/24)
- Georgia patients struggle to find drugs they need due to shortages- The Atlanta Journal-Constitution (3/06/24)
- Overruling Chevron and FDA Decision Making, by Nikhil Chaudhry, Dr. Reshma Ramachandran, and Dr. Joseph Ross (2/09/2024)
- Reshma Ramachandran: Will the Supreme Court Upend Healthcare Regulation? – Yale Insights: Health & Veritas with Howard P. Forman and Harlan M. Krumholz (1/18/2024)
- The F.D.A. Warned an Asthma Drug Could Induce Despair. Many Were Never Told. – The New York Times (1/09/24)
Op-Eds
- Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications (12/03/24)
- Representativeness of Studies Required Under Medicare's Coverage With Evidence Development Program (11/13/24)
- Industry Payments to Physicians by Competing Manufacturers Within Novel Therapeutic Classes (11/07/24)
- Adoption of the voluntary conflict of interest statement on PubMed (10/30/25)
- Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence (10/26/24)
- National Trends in and Concentration of Industry Payments to U.S. Psychiatrists, 2015-2021 (10/23/24)
- Temporary FDA Advisory Committee Members, Recommendations, and Agency Actions, 2017-2021(10/01/24)
- Class I Recalls of Cardiovascular Devices Between 2013 and 2022 (9/17/24)
- Counting on Insulin Manufacturers To Do the Right Thing is Not a Good Policy Prescription to Avert Shortages- Health Affairs (7/12/2024)
- Harnessing policy to promote inclusive medical product evidence: development of a reference standard and structured audit of clinical trial diversity policies-BMJ Medicine (7/11/24)
- The Future of FDA Advisory Committees: Protecting Public Health and Preserving Public Trust-Health Affairs (7/01/24)
- Estimating The Effects OF COVID-19 On Globalized Markets For Active Pharmaceutical Ingredients-Health Affairs (7/2024)
- To receive testimony on the Department o... | U.S. Senate Committee on Armed Services- United States Senate Committee on Armed Services (4/12/24)
- Victory Over Big Pharma Will Take More Than the IRA | MedPage Today (4/04/24)
- Implications for Public Health Regulation if Chevron Deference Is Overturned- JAMA (3/20/24)
Public Comments
- Amicus Brief for American Clinical Laboratories Association, et al v US Food and Drug Administration, et al and Association for Molecular Pathology, et al v US Food and Drug Administration, et al (11/04/24)
- Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability (9/27/24)
- Comments on FDA-2021-D-0789: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (9/26/24)
- Comments on FDA-2017-D-0154: Considerations in Demonstrating Interchangeability With a Reference Product: Update (8/20/24)
- Comments on National Institutes of Health (NIH) Office of Science Policy: Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning (7/22/24)
- Amicus Brief for The Center For Investigative Reporting And Will Evans v Dept of Labor (7/17/24)
- Comment on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 (7/02/24)
- Comment FDA-2016-D-3561: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (4/29/2024)
- Comment on FDA-2023-D-4395: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry (2/20/2024)
- Comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, National Institute of Standards and Technologies (NIST), United States Department of Commerce. 88 FR 85593, Docket No.: 230831-0207 (2/06/24)
- Transforming Clinical Trial Results: Report (Published in Universities Allied for Essential Medicines (4/22/24)