On December 3, 2020, the Secretary of the Department of Health and Human Services issued a fourth amended PREP Act declaration expanding the scope of immunity for covered entities engaged in the provision of goods and...more
On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. While the...more
As we previously reported, on March 10, 2020, the Secretary of Health and Human Services, acting under the authority provided by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act), issued a Declaration...more
Since invoking its powers under the PREP Act last month to shield certain actors aiding in the fight against COVID-19 from tort liability for their efforts, the Department of Health and Human Services (“HHS”) has been...more
“This is a rapidly evolving situation and CDC will provide updated information and guidance as it becomes available.” This statement is the headline to the CDC’s Situation Summary for COVID-19. ...more
On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that...more