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 same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business. 

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.

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.

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 review the agency’s internal processes to find better ways to get things done. Read more

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 had confronted issues that “have tested our regulatory frameworks and stressed the agency’s operations,” prompting the review announced on Tuesday.

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 Alzheimer’s drugs. Read more here.

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 at the Reagan Udall Foundation for the FDA’s annual public board of directors meeting. Read more here.

-Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual 

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 time, according to FDA Commissioner Robert Califf.