Amid controversies, FDA seeks advice on food and tobacco operations - The Washington Post

The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile issues: the infant-formula shortage and e-cigarettes, particularly the vaping company Juul.

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 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. 

Amid controversies, FDA seeks advice on food and tobacco operations

The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile issues: the infant-formula shortage and e-cigarettes, particularly the vaping company Juul. Read more

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

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

Therapeutics/Vaccines Lab Meeting

Join us Thursday, July 21 at 3 pm ET for the July Therapeutics & Vaccines lab Meeting. We’ll be hearing from Elizabeth Eldridge of Health Catalyst. Liz will be describing the new research project they are taking on at the request of the Evidence Accelerator, looking at the use of dexamethasone in COVID-19 patients. 

In addition, we will be receiving an update on the Real-World Evidence Online Primer.

Diagnostics Lab Meeting

Join us Thursday, July 21 at noon ET to hear from Dr. Keith Campbell of FDA's Center for Devices and Radiological Health. He'll be speaking about Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), a public-private initiative to develop and launch collaborative policies and business models designed to overcome barriers to the interoperability of laboratory data.  Dr. Campbell will be providing an update about SHIELD from FDA’s perspective.