Tag: Dr. Robert Califf

Dr. Robert Califf

Regulatory/FDA

Myers: Data Will Drive Califf’s Decisions at FDA

Myers: Data Will Drive Califf’s Decisions at FDA

March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]

Read more

Regulatory/FDA

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process

March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]

Read more