The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
10/31/2023
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Pharmaceutical Industry ,
Prescription Drugs ,
Technology Sector ,
Telemedicine
In light of the August 30, 2023 historic recommendation from the U.S. Department of Health and Human Services (HHS) to reschedule cannabis to Schedule III, a multidisciplinary group of attorneys from Foley Hoag’s nationwide...more
9/1/2023
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Penalties ,
DEA ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Medical Marijuana ,
Schedule I Drugs
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents.
The Transition...more
The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more
Key Takeaways:
The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.
FDA’s recommendations come as part of increasing interest in ensuring clinical...more
4/20/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Black and Minority Ethnic (BME) ,
Clinical Trials ,
Corporate Counsel ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
FDASIA ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Licenses ,
National Institute of Health (NIH) ,
Premarket Approval Applications ,
Sponsors