Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more
Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans. The FDA alerted clinical laboratory staff and health care professionals...more
Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and provided recommendations on the COVID-19 booster dose, and yesterday the FDA authorized the booster dose for certain...more
Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply...more
Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more
Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House...more
Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more
Last week, the Administration’s COVID-19 Response Team reported that the case numbers continue to rise in low-vaccination states, with most infections as a result of the Delta variant. Vaccination rates, however, are starting...more
Last week, the Centers for Disease Control and Prevention (CDC) revised its mask guidance for fully vaccinated individuals. Also, while the Administration and several health care institutions evaluate the possibility of...more
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
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries.
This month, plaintiffs can’t remember the taste...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries.
This month, someone moved someone’s smoked...more
4/30/2021
/ Advertising ,
Animal Food ,
Class Action ,
Dietary Supplements ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Labeling ,
Manufacturers ,
Marketing ,
Nutrition Facts Labels ,
Product Labels ,
Putative Class Actions ,
Settlement
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries.
This month, the Ninth Circuit gets krabby,...more
4/2/2021
/ Advertising ,
Animal Food ,
Class Action ,
Class Certification ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Marketing ,
Food Recalls ,
Marketing ,
Settlement
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
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and settlements affecting the agribusiness, food, beverage, and cosmetics industry.
This month, not all Ritas are lovely, someone...more
Whether your products are used for medical purposes or used in homes and offices, our Food, Drug & Device/FDA and Environment, Land Use & Natural Resources teams highlight the key regulatory requirements that apply, what has...more
Our Food & Beverage and FDA teams explore recent updates from the Food and Drug Administration and Department of Agriculture on their food safety enforcement approaches to the evolving coronavirus (COVID-19) pandemic....more
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s decision to temporarily postpone routine surveillance domestic inspections in the wake of the continuing coronavirus (COVID-19) outbreak....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