FDA Panel Endorses New Alzheimer’s Drug After Accelerated Approval
The newest Alzheimer’s drug is on its way for full regulatory approval after a U.S. Food and Drug Administration (FDA) advisory panel voted that the drug was beneficial in slowing cognitive decline. The drug is expected to be fully approved by July 6, 2023.1 In clinical trials the drug, known as lecanemab, demonstrated a 27 […]
FDA Criticized for Working Too Closely With Biotech Company to Approve Alzheimer’s Drug
New findings from a congressional investigation into the Food and Drug Administration and the biotech company Biogen find that the FDA broke its own protocols to approve a new Alzheimer’s drug last year. The findings conclude that the regulator worked too closely with Biogen, despite significant concerns over the limited and side effects of the […]
The Declining Standards of FDA Drug Approvals
The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline. The Need for Speed Since the enactment of […]
Why are Standards So Lax on COVID Drug Approvals?
Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet. First, consider that EUA ( emergency use authorization) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that […]
Two FDA Officials Resign Over White House Booster Shot Decision
Two senior officials of the U.S. Food and Drug Administration (FDA) have stepped down from the COVID vaccine review team at a critical time in the approval process. While the FDA did not cite a specific reason for the departure of two veteran officials, Endpoints News reports that widespread frustration in the regulatory agency began […]
