Last week, FDA Acting Commissioner Janet Woodcock testified before Congress on the role of the agency in the COVID-19 response and the way forward. The Administration reaffirms its commitment to combat the national and global...more
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
Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. ...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