Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
On April 24, 2020, the FDA issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19. These side effects include serious and...more
Recent developments in Italy in response to the COVID-19 public health crisis: The Cura Italia Decree provides for public funds to support increased production of medical devices and personal protective equipment (PPE) and...more
Production of animal food, like human food, is an essential function Americans depend on daily, reinforced by the Department of Homeland Security in its Guidance on the Essential Critical Infrastructure Workforce: Ensuring...more
As the novel coronavirus (COVID-19) crisis continues to present new questions and challenges, the U.S. Food and Drug Administration (FDA) continues to update its website to provide additional information and guidance to the...more