Preview

TODAY ON THE BLOG

COVID-19

The Food and Drug Administration (FDA) outlines the regulatory landscape and major policy considerations for the three key components of the COVID-19
response—testing, therapeutics, and vaccines—in a four-part series today on Health Affairs Blog.

And for more on COVID-19 vaccines and treatment, RSVP now for a Health Affairs symposium on August 24.

The FDA Response To COVID-19 At Six Months: Regulatory Innovation In The Face Of A Pandemic
By Anand Shah and Stephen M. Hahn

We hope that chronicling and communicating FDA’s actions to date will spur conversation from stakeholders about what lessons the agency can draw from the pandemic experience to support short- and long-term steps to modernize regulatory policies, processes, and programs.
Read More >>

FDA Support For Expedited Access To COVID-19 Diagnostics
By Anand Shah, Jeffrey Shuren, and Stephen Hahn

The agency is committed to providing interactive regulatory support for test design and collaborating with partners to share data for performance validation to help expand access to accurate tests for COVID-19. Read More >>

FDA Initiatives To Accelerate The Development Of COVID-19 Therapeutics
By Anand Shah, Kushal T. Kadakia, Peter W. Marks, Patrizia Cavazzoni, and Stephen M. Hahn

As the medical and scientific community works to broaden the therapeutic toolkit for COVID-19, FDA is committed to reviewing investigational programs, policies, and partnerships with the aim of providing a clear path forward for the rigorous development of new therapies for the pandemic and possibly beyond. Read More >>

Ensuring The Safety And Efficacy Of A COVID-19 Vaccine
By Anand Shah, Peter W. Marks, and Stephen M. Hahn

Access to a safe and effective vaccine will be a critical component of the public health response to the COVID-19 pandemic. The FDA is hopeful that its proactive guidance on key issues such as trial design and statistical considerations will provide regulatory clarity to sponsors that are currently in the process of planning clinical trials. Read More >>

FOLLOWING THE ACA

Court Vacates New 1557 Rule That Would Roll Back Antidiscrimination Protections For LGBT Individuals
By Katie Keith

In the first of several coming rulings on the Trump administration’s new rule implementing the Affordable Care Act’s primary antidiscrimination provision, the court said that the government had acted arbitrarily and capriciously in not revisiting its definition of discrimination “on the basis of sex” after the Supreme Court rejected that interpretation. Read More >>

IN THE JOURNAL

RESEARCH ARTICLE: COVID-19

Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US
By Wei Lyu and George L. Wehby

This landmark paper finds that face mask use possibly averted 230,000–450,000 cases of COVID-19 by May 22, 2020. Cited in more than 350 news stories and tweeted by thousands, it has been used by policy makers in many US states as well as countries around the world in support of face mask mandates. The peer-reviewed, unedited version of the paper was previously released online as a Health Affairs Fast Track Ahead-of-Print paper.