Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more
Last week, President Biden signed a comprehensive pro-competition Executive Order with various requirements affecting medical product supply chains, such as the ability to import prescription drugs from Canada and banning...more
Last week, the White House released a framework for U.S. leadership in the global COVID-19 response. In addition, the FDA is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators...more
What are the benefits and drawbacks of coming to an independent generally recognized as safe (GRAS) conclusion for a novel food ingredient compared to filing a GRAS notification with the FDA? Our Food & Beverage and FDA teams...more
What does it take to clear regulatory hurdles to bring food and drugs to market? Our Food & Beverage and FDA teams begin a series exploring best practices for you to follow and the many avenues to approval and success. First:...more
The Food and Drug Administration released guidance for the use of convalescent plasma to treat COVID-19 to supplement its recently issued emergency use authorization. Our Food, Drug & Device/FDA Team analyzes the specifics of...more
The Food and Drug Administration (FDA) is racing to make coronavirus tests more widely available. Our Food, Drug & Device/FDA Team examines how the FDA is using its authority to issue emergency use authorizations (EUAs) to...more
Our Food, Drug & Device/FDA Team discusses why the Food & Drug Administration is engaging with personal protective equipment (PPE) manufacturers and how it’s providing information to health care providers to mitigate...more
Our FDA Compliance & Enforcement Team examines the Food & Drug Administration’s decision to stop overseas inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more