Our FDA and Food & Beverage teams outline key requirements of the Modernization of Cosmetics Regulation Act (MoCRA) and provide key takeaways from the Food and Drug Administration’s new draft guidance on facility registration...more
Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more
In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
2/1/2022
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Supply Chain ,
Vaccinations
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more
Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more
Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more
In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...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, yellow cellophane rose-tints the...more
Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for over-the-counter (OTC) hearing aids. The...more
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
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
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, something something memory...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, 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
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
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