- October 12, 2023
Welcome New Staff, Faculty, Postdocs & Postgrads! (October 2023)
- October 05, 2023
Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone
- September 11, 2023
Yale Open Data Access Project Reaches Milestone in Helping to Maximize the Use of Clinical Trial Data for Research
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On this page
2023
- Top Patient Advocacy Orgs Have Industry Ties in Leadership, Study Shows (Published in MedPage Today on 8/21/23)
- Alzheimer's drug Leqembi may not work as well on women (Published in Axios on 7/11/23)
- Ozempic's maker bought prescribers over 450,000 meals last year (statnews.com) (Published in Stat News on 7/05/23)
- Is a gift ever just a gift? (Published in GoozNews on 6/30/23)
- FDA’s Peter Marks overrode agency staff to approve Sarepta’s Duchenne gene therapy (Published on 6/23/23)
- When Dying Patients Want Unproven Drugs (Published in The New Yorker on 6/19/23)
- The strain COVID vaccines might target next (Published in AXIOS on 6/15/23)
- How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful? (Published in Pink Sheet on 6/12/23)
- FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s advisory panel (Published in Stat News on 6/05/23)
- Promising new Alzheimer's drugs present patients with tough choices (Published in AXIOS on 5/15/23)
- Gene therapy for muscular dystrophy stirs hopes and controversy (Published in NPR & Houston Public Media on 5/02/23)
- Will New FDA Rules Help Dial Back Expedited Drugs? (Published in Undark Magazine on 4/12/23)
- Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd (Published in Pink Sheet on 3/13/23)
- Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups (Published in Medical Xpress on 2/23/23)
- Gold standard? 10% of newly approved drugs were based on studies that didn't achieve goals (Published in USA Today on 2/13/23)
- Lack of diversity in clinical trials is leaving women and patients of color behind and harming the future of medicine – Podcast (Published in The Conversation on 2/9/23)
- Health experts want FDA safety review of fast-tracked Alzheimer's drug (Published in AXIOS on 2/6/23)
- Loophole enables FDA approval of unsafe medical devices, Yale study finds (Published in Yale News on 1/19/23)
- Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax (Published in Pink Sheet on 1/16/23)
- New Alzheimer's drug may have limited real-world impact (Published in AXIOS on 1/10/2023)
- Approval of a second controversial Alzheimer's drug is dividing medical experts (Published in The Washington Post on 1/9/23)
2022
- Speedier drug approvals hit slowdown as FDA faces scrutiny (Published in AP News on 12/7/22)
- Covaxin Was Rushed Under Political Pressure, Need for Speed: STAT Report (Published in The Wire on 11/16/22)
- GSK’s Blenrep for Multiple Myeloma Misses Mark in Phase III Confirmatory Trial (Published in Biospace on 11/7/22)
- Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period (Published in Pink Sheet on 11/1/22)
- FDA explains why it won’t pull Jazz’s accelerated approval despite a failed confirmatory trial (Published in Endpoints News on 10/26/22)
- Time for Changes at the FDA, Expert Group Says (Published in MedPage Today on 10/21/22)
- Better Antibiotic Trials Sought as Congress Weighs Funding Bill (Published in Bloomberg Law on 10/19/22)
2021
- Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements (published in JAMA on 11/12/21) – Reshma Ramachandran, Christopher J. Morten, Joseph S. Ross
- Fulfilling the Mandate of the US Food and Drug Administration’s Accelerated Approval Pathway: The Need for Reforms (published in JAMA Internal Medicine on 7/13/21) - Bishal Gyawali, Joseph S. Ross, Aaron S. Kesselheim
- Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown (published in New England Journal of Medicine on 3/25/21) - Vinay K. Rathi, James L. Johnston, Joseph S. Ross, and Sanket S. Dhruva
- A first for Medicaid unwinding (Published in Politico on 8/23/23)
- Alzheimer’s Groups Seek Broad Medicare Coverage for Pricey Drugs (Published in Bloomberg Law on 6/01/23)
- Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy? (Published in MedPage Today on 5/18/23)
- Adding device identifiers to claims forms—a key step to advance medical device safety (Published in the BMJ on 1/11/23)
- Why the PASTEUR Act is no cure for antimicrobial resistance (Published in The Hill on 12/13/22)
- Congress Should Take This Chance to Fix Clinical Trial Diversity (Published in Bloomberg Law on 12/22/22)
- Spontaneous reporting of post-market safety signals: what evidence should support regulatory action? (Published in the BMJ on 10/05/22)
2023
- Comment on Draft Guidance, (FDA-2023-D-0559) “Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.” (Submitted on 9/11/23) – Reshma Ramachandran, Joseph Ross, Joshua Wallach
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Comment on “CMS Coverage with Evidence Development Proposed Guidance Document” (submitted on 8/21/23)— Maryam Mooghali, Osman Moneer, Nikhil Chaudhry, Reshma Ramachandran
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Comment on Draft Guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.” (submitted on 7/10/23) – Sanket S. Dhruva, Molly M. Jeffery, Joseph S. Ross
- Comment on Pandemic and All-Hazards Preparedness Act (PAHPA) Discussion Draft to the Senate Health, Education, Labor, and Pensions Committee (submitted on 7/10/23) – Reshma Ramachandran, Nikhil Chaudhry
- Response to Request for Information from Senator Mike Crapo and Chairwoman Cathy McMorris-Rodgers on Drug Shortages (submitted on 7/7/23) – Nikhil Chaudhry, Melissa Barber, Inmaculada Hernandez, Stacie B. Dusetzina, Joseph S. Ross, Reshma Ramachandran
2022
- Comment on Draft Guidance (FDA–2021–D–0789): Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (submitted on 6/10/21) – Jennifer E. Miller, Joseph S. Ross, Reshma Ramachandran, Cary Gross
- Comment on CMS Interim Rule for Prescription Drug and Health Care Spending - CMS-9905-IFC (submitted on 1/25/22) - Kamil F. Faridi, Reshma Ramachandran, Sanket S. Dhruva, Nihar R. Desai, Khera, Khurram Nasir, Harlan M. Krumholz, Joseph S. Ross
- Comment on CMS’s Proposed Decision Issued in Response to the National Coverage Analysis “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” (submitted 2/8/22)
2021
- Comment on Draft Guidance (FDA-2020-D-2307), “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products” – Sanket S. Dhruva, Reshma Ramachandran, Joseph S. Ross