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, 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
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
Carbon capture and storage could play a major role in a Biden Administration eager to rejoin the Paris Agreement. Our Federal Tax Group provides a brief overview of the 45Q credit and key takeaways from the IRS’s new final...more
Our Environment, Land Use & Natural Resources Group explains how companies can benefit from the Environmental Protection Agency’s new interim guidance expediting the product registration process for long-lasting antimicrobial...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
On August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally. The sewer ban component of the new rule applies in all states....more
On December 12, 2018, the EPA released its long-awaited Management for Hazardous Waste Pharmaceuticals Rule. The EPA addressed industry concerns by amending the hazardous waste listing for nicotine to exclude nicotine...more
All entities selling drugs and sharps in California should be aware of California’s pharmaceutical and sharps waste stewardship bill, SB 212, which recently passed both houses of the state Legislature. ...more
Washington recently passed legislation that will examine and possibly lead to a ban on perfluorinated chemicals (PFAs) in food packaging. Under Washington’s Healthy Food Packaging Act (H.B. 2658/S.B. 6396), which takes...more
On June 5, 2017, Attorney General Jeff Sessions issued a memo prohibiting DOJ from including payments to third party non-government entities in civil and criminal settlements. This memo will have far reaching consequences...more
Last August, the U.S. Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) finalized the more stringent “Phase 2” greenhouse gas (GHG) emission standards and fuel efficiency...more
As expected, on January 12, 2017, the U.S. Environmental Protection Agency (EPA) issued its Final Determination affirming the greenhouse gas (GHG) emission standards for model year 2022-2025 light-duty vehicles. While EPA...more
EPA has released its long-awaited proposed CERCLA financial assurance regulations for the hardrock mining industry. When finalized, these regulations will serve as a model for financial assurance regulations for other...more
Through its Proposed Determination, EPA has concluded that the model year 2022-2025 GHG standards should remain as promulgated, despite automotive industry evidence demonstrating the need for less stringent standards. ...more
On November 3, the California Air Resources Board (CARB) announced plans for a new low-nitrogen oxide (NOx) standard for heavy-duty engines sold in the state. CARB intends to adopt the new NOx standard—of 0.02 grams per...more
Originally published in Bloomberg BNA's Daily Environment Report, 209 DEN B-1, 10/28/16.
On Oct. 25, the Environmental Protection Agency and the National Highway Traffic Safety Administration published more stringent...more