President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
6/24/2025
/ Anti-Competitive ,
Biosimilars ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Imports ,
Most-Favored Nations ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Trump Administration
FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited.
On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more
9/10/2024
/ Administrative Procedure Act ,
Chevron Deference ,
E-Cigarettes ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Authority ,
Statutory Interpretation ,
Tobacco ,
Tobacco Regulations
Agency works to speed approvals and improve access to generic prescription drugs.
In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more
Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” -
On January 18, 2017, the US Food and Drug Administration (FDA or...more