Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
7/26/2024
/ Agribusiness ,
Biologics ,
Biotechnology ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Genetically Engineered Animals ,
Genetically Engineered Seed ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Mitigation ,
USDA
Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...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
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, 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, 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, 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