2022
On this page
Perspectives, Viewpoints, and Editorials
- 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
Public Comments
- Comment on Draft Guidance (FDA–2021–D–0789): Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (6/10/21)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)