Stakeholder Input Sought in Evaluation of FDA Human Foods Program- Food Safety Magazine

The Reagan-Udall Foundation opened a Stakeholder Portal on September 16, 2022, to collect perspectives and experiences with the U.S. Food and Drug Administration’s (FDA's) human foods program. In addition, the Foundation announced a public meeting of its food-focused Independent Expert Panel.

Public Meeting of the Independent Expert Panel - FDA Human Foods Program

Join us to observe the in-person public meeting of the Food Independent Expert Panel on September 29 & 30. We'll be gathering input from invited stakeholders including consumer, research/academia, government, and industry representatives. You can join in-person (limited space available) or virtually (audio-only feed). During registration you can choose to attend the full meeting virtually or in-person. Note: if attending in person, you must register for each day separately that you want to attend.

Skin lightening products are a 'regulatory black hole,' and the FDA is warning against using them - USA Today

The FDA has launched an initiative warning about over-the-counter skin lightening products after receiving reports of side effects.

The agency's Skin Facts! Initiative, announced last week, is aimed at promoting safe use of skin care products, urging people to be aware of non-prescription products marketed to lighten or bleach the skin.

Therapeutics and Vaccines Lab Meeting

Eric Young of TriNetX will take us through the characterization of breakthrough infections for vaccinated individuals, including children, who received both outpatient and inpatient treatment. Sonia Hernandez-Diaz, Harvard T.H. Chan School of Public Health, will share her experience with “Target trial emulation to evaluate COVID-19 vaccination during pregnancy” using RWD from Israel. Carla Rodriguez-Watson will preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.

Diagnostics Lab Meeting

 Professor Mara Aspinall of the Diagnostic Commons housed at Arizona State University will join us to reflect on the past, present and future of diagnostic tests. Matthew Gee of Siemens will take a look at lessons learned from using real-world data in regulatory submissions for COVID diagnostics tests. Carla Rodriguez-Watson will provide a preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.

FDA Voices: FDA's Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death

In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal costs as people and families grapple with substance use disorder (SUD). Due to this unfortunate reality, in 2017 the opioid crisis was determined to be a public health emergency, which to this day is still in effect. Today’s drug overdose crisis is multifaceted and has evolved beyond prescription opioids.

Experts Announced for Review of FDA Human Foods Program

(September 1, 2022) The Reagan-Udall Foundation today announced five members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. Joining Henney are Francisco Diez-Gonzalez, James Jones, Barbara Kowalcyk, Shiriki Kumanyika, and John Taylor.