Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of...more
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more
The coming end to the COVID-19 public health emergency doesn’t mean the end of all FDA authorities exercised during the pandemic. Our FDA/Food, Drug & Device Team explores what will happen to the FDA’s emergency use...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 two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...more
In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more
In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster for all...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
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
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