US FDA's newly appointed drugs chief set to retire

The U.S. Food and Drug Administration's drug evaluation chief, Richard Pazdur, is set to retire just weeks after taking the ...
NPR

A History of FDA Action on Antidepressants

In 2004, the suicide rate among U.S. teens increased for the first time in a decade, according to a recent CDC report. That year also saw a noted decline in the use of antidepressants among children ...
BioSpace

As CGT Struggles To Scale, FDA’s New Designation Could Smooth Post-Approval Pivots

Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production ...
Cult of Mac

In a first, Apple Watch AFib History gains special FDA qualification

For the first time, the U.S. Food and Drug Administration (FDA) qualified a digital technology — Apple Watch’s AFib History feature — for a special research program. AFib, or atrial fibrillation, is a ...
The Atlantic

A People's History of FDA Approval Inspiring Conspiracy and Murder in Fiction

Which government agency wields the most menacing power? The CIA? NSA? IRS? No, it’s the deceptively banal Food and Drug Administration. Just ask Sarepta Therapeutics. And it does, just not in real ...
MacRumors

Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature ...
Time

Whither Qnexa? A Brief History of Diet Pills and the FDA

Will the second time will be the charm for the diet drug Qnexa? The Food and Drug Administration (FDA) is reviewing the data on the weight-loss medication, again — an advisory panel will meet on ...
Davis VanguardOpinion

Drug Historian Challenges Trump’s Narrative on Fentanyl Crisis

A recent New York Times opinion piece argues that the fentanyl crisis is rooted in the history of domestic drug markets and U ...
BioSpace

FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’

Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for ...