Jan 7, 2022 | FDA, Letters Submitted
The FDA’s Accelerated Approval Program provides a path for earlier approval of drugs being developed to treat serious diseases and address unmet medical need. The process allows the use of a surrogate endpoint—an indirect marker of clinical benefit that allows the...
Read more
Jan 7, 2022 | FDA, Letters Submitted
On behalf of Patients Rising, the organization representing millions of Americans living with chronic disease, I write to support the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration. The U.S. Food and Drug Administration...
Read more
Aug 9, 2021 | FDA, Featured, ICER, Podcast
On this episode of the podcast, Bob and Kate, filling in for Terry, discuss the attack on Food and Drug Administration accelerated approvals. They point to the recent criticism of the breakthrough Alzheimer’s drug Aduhelm as Exhibit A. Bob explains how...
Read more
