The Hill

FDA’s accelerated approval process is good enough for cancer and AIDS. Why not Alzheimer’s?

The U.S. Food and Drug Administration’s (FDA) approval of the first-ever disease-slowing therapy for Alzheimer’s has given hope to millions of Americans, their families, and caregivers who are all ...
JD Supra

Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval

On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations ...
JD Supra

Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context

On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple ...
Labroots

Accelerated Removal of the Previous Approval

The FDA’s accelerated approval process had attracted criticism from researchers, FDA advisory committee members, and now congress. It was originally designed in 1992 to fast tract treatments for ...