STAT1h
Patrizia Cavazzoni, head of FDA’s drug center, to leave the agency
Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.
FiercePharma3h
FDA cancels adcomm in 'positive' sign for Exelixis’ Cabometyx bid in neuroendocrine tumors: analyst
On second thought, the FDA figures it no longer needs to discuss Exelixis’ application for Cabometyx in neuroendocrine tumors ...
FiercePharma2h
FDA's Patrizia Cavazzoni to retire as CDER chief in 2nd senior official's departure in span of weeks
The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire ...
Pizza Recall Update As FDA Sets Risk Level Over Plastic Contamination
The recalled "Connie's Thin Crust Cheese Pizza" was issued a Class II risk level by the FDA, the second-most severe risk ...
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
STAT1d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
FDA sets limits for lead in many baby foods as California disclosure law takes effect
The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
Healio4h
Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
ConsumerAffairs22h
Watchdog report finds FDA lags in food inspection duties
The U.S. food supply is generally considered safe, but tens of millions of people get sick from foodborne illnesses each year ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...