Coverage

FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations
In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. Yet at the…
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FDA announces external review of food safety and tobacco regulatory offices - POLITICO
Food and Drug Administration Commissioner Robert Califf said on Tuesday that he has ordered an external review of the agency’s offices on food safety and tobacco regulation.
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FDA weighs oversight changes after formula, Juul troubles - Associated Press
The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
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FDA leader hiring affiliated foundation to review problems at food side of agency - Food Safety News
A shakeup of the chain of command at the FDA may be coming, but the beginning of the release of details is at least 60 working days away. FDA Commissioner Dr. Robert Califf told Food Safety News today that the agency has hired an outside company to…
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F.D.A. Seeks Outside Review of Troubled Food and Tobacco Units - New York Times
The Food and Drug Administration has commissioned a review of its food and tobacco programs following public outrage over baby formula  shortages and concerns about flavored nicotine products. Dr. Robert Califf, the head of the F.D.A., said the agency…
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Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s - Pink Sheet
Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for…
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Woodcock Weighs in on ARPA-H - POLITICO's Prescription Pulse
If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday…
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Global Genes and the Orphan Disease Center of the University of Pennsylvania Host 7th Annual RARE Drug Development Symposium - Yahoo Finance
-Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual 
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FDA says IT modernization came at right time for COVID - Regulatory Focus
While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in…
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FDA’s Technology and Data Modernization in Action in 2022
In partnership with the Reagan-Udall Foundation, the FDA and the Friends of Cancer Research launched the Evidence Accelerator (EA) to advance the use of Real-World Data (RWD) to inform the COVID-19 response. In collaboration, ODT and the FDA’s Office of…
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