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.
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.
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.
Beyond the learning acceleration of our COVID-19 Evidence Accelerator lab meetings, the Evidence Accelerator model includes “engines” of evidence generation. At the June 16th Therapeutics and Vaccines meeting, we’ll review the results and performance of one of those engines, and help jump-start a new engine.
Join the COVID-19 Diagnostics Evidence Accelerator to check-up on what’s happening with the Mayo Clinic. Since Mayo’s (and their research partners at Yale University) participation in our research project looking at use patterns and performance of serological tests, they have continued to track and evaluate use of COVID-19 tests within their health system. We’ll learn how testing patterns have changed, and what information they have gathered (and generated) regarding test performance.
