- Podcast: Non-binding Guidance: COVID-19 Vaccine Mandate Litigation
(July 29, 2021) - Podcast: Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic
(May 27, 2021) - FDA Announces It Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests
(October 9, 2020) - Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and the Impact of the Pandemic
(September 30, 2020) - HHS Prohibits FDA from Requiring Premarket Review of LDTs, Including During the COVID-19 Emergency
(August 25, 2020) - Analysis: FDA Response to COVID-19: A Shifting Landscape
(June 29, 2020) - Cares Act Includes Overhaul of Over-The-Counter (“OTC”) Drug Monograph Framework
(May 14, 2020) - FDA Walks Back Enforcement Discretion for Commercially Manufactured Serology Tests
(May 6, 2020) - FDA and NIH Release Guidance on Ongoing Clinical Trials Affected by COVID-19
(March 27, 2020) - Will the Coronavirus Spur Passage of LDT Reform Legislation?
(March 25, 2020)