Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
7/16/2025
/ Biologics ,
Consumer Protection Laws ,
Drug Pricing ,
Enforcement Actions ,
Expedited Approval Process ,
Expedited FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Recalls ,
Proposed Regulation ,
Public Policy ,
Regulatory Agenda ,
Regulatory Reform
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...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