2023
On this page
Perspectives, Viewpoints, and Editorials
- Data Sharing—A New Era for Research Funded by the U.S. Government (12/28/2023)
- Geographic and Demographic Representation in Industry-sponsored, US-based Clinical Trials of Systemic Lupus Erythematosus Therapies (12/15/2023)
- Rx Shortages Prompt Search by Congress for a Lasting Solution ( 12/01/23)
- Huge Spending — But Little Sharing of Research Results — on Cancer Drugs (11/15/23)
- Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics (11/03/2023)
- Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program (10/25/2023)
- Americans Don’t Get to Have the Best New COVID Drug - The Atlantic (Published on 10/25/23)
- Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone. (10/05/2023)
- Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative (9/28/23)
- Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment (9/28/23)
- The Accelerated Approval Program for Cancer Drugs — Finding the Right Balance (9/14/23)
- Top Patient Advocacy Orgs Have Industry Ties in Leadership, Study Shows (8/21/23)
- Alzheimer's drug Leqembi may not work as well on women (7/11/23)
- Ozempic's maker bought prescribers over 450,000 meals last year (statnews.com) ( 7/05/23)
- Is a gift ever just a gift? (6/30/23)
- FDA’s Peter Marks overrode agency staff to approve Sarepta’s Duchenne gene therapy (6/23/23)
- When Dying Patients Want Unproven Drugs (6/19/23)
- The strain COVID vaccines might target next (6/15/23)
- How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful? (6/12/23)
- FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s advisory panel (6/05/23)
- Promising new Alzheimer's drugs present patients with tough choices (5/15/23)
- Gene therapy for muscular dystrophy stirs hopes and controversy (5/02/23)
- Will New FDA Rules Help Dial Back Expedited Drugs? (4/12/23)
- Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd (3/13/23)
- Clinical trials on new cancer drugs still fall far short of including key data on several demographic groups (2/23/23)
- Gold standard? 10% of newly approved drugs were based on studies that didn't achieve goals (2/13/23)
- Lack of diversity in clinical trials is leaving women and patients of color behind and harming the future of medicine – Podcast (2/09/23)
- Health experts want FDA safety review of fast-tracked Alzheimer's drug ( 2/06/23)
- Loophole enables FDA approval of unsafe medical devices, Yale study finds (1/19/23)
- Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax (1/16/23)
- New Alzheimer's drug may have limited real-world impact (1/10/2023)
- Approval of a second controversial Alzheimer's drug is dividing medical experts ( 1/09/23)
Op-Eds
- Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics (12/11/2023)
- Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment ( 9/28/23)
- A first for Medicaid unwinding (8/23/23)
- Alzheimer’s Groups Seek Broad Medicare Coverage for Pricey Drugs ( 6/01/23)
- Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy? (5/18/23)
- Adding device identifiers to claims forms—a key step to advance medical device safety (1/11/23)
Public Comments
2023
- Comment on FDA-2023-D-2318: Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (12/18/23)
- Comment on FDA-2023-D-3134: Best Practices for Selecting a Predicate Device to Support a Premarket 510(k) Submission (12/05/23)
- Comment on FDA-2023-D-3133: Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (12/05/23)
- Comment on FDA-2023-D-3132: Evidentiary Expectations for 510(k) Implant Devices (12/05/23)
- Amicus Brief for Relentless v Dept of Commerce (Supreme Court case that may overturn federal agency deference)” (12/2023)
- 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.” (9/11/23)
- Comment on “CMS Coverage with Evidence Development Proposed Guidance Document” ( 8/21/23)
- Comment on Draft Guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.” ( 7/10/23)
- Comment on Pandemic and All-Hazards Preparedness Act (PAHPA) Discussion Draft to the Senate Health, Education, Labor, and Pensions Committee (7/10/23)
- Response to Request for Information from Senator Mike Crapo and Chairwoman Cathy McMorris-Rodgers on Drug Shortages (7/07/23)