2022
Perspectives, Viewpoints, and Editorials
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- Speedier drug approvals hit slowdown as FDA faces scrutiny (12/07/22)
- Covaxin Was Rushed Under Political Pressure, Need for Speed: STAT Report (11/16/22)
- GSK’s Blenrep for Multiple Myeloma Misses Mark in Phase III Confirmatory Trial (/07/22)
- Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period (11/01/22)
- FDA explains why it won’t pull Jazz’s accelerated approval despite a failed confirmatory trial (10/26/22)
- Time for Changes at the FDA, Expert Group Says (10/21/22)
- Better Antibiotic Trials Sought as Congress Weighs Funding Bill (10/19/22)
Op-Eds
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Public Comments
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- Comment on Draft Guidance (FDA–2021–D–0789): Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (6/10/21)
- Comment on CMS Interim Rule for Prescription Drug and Health Care Spending - CMS-9905-IFC (1/25/22)
- 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” (2/08/22)
Letters to Policymakers
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- Joint Sign-On Letter with Academics and Advocacy Organizations to Senate Health, Education, Labor, and Pensions Leadership on Public Interest Riders to be included in FDA User Fee Legislation (5/20/22)