“You may choose to look the other way, but you can never say again that you did not know.”
— William Wilberforce
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 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 […]
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 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 […]