The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules...more
The U.S. Drug Enforcement Agency Administration (DEA) and U.S. Department of Health and Human Services (HHS) (collectively, the Agencies) on Nov. 11, 2024, issued a third extension of their telemedicine flexibilities for the...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
9/17/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Genetic Testing ,
Inspections ,
Laboratory Developed Tests ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Social Security Act ,
Warning Letters ,
Work Plans