Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more
7/11/2024
/ Administrative Procedure Act ,
Biologics Price Competition and Innovation Act of 2009 ,
Chevron Deference ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Jurisdiction ,
Loper Bright Enterprises v Raimondo ,
Prescription Drugs ,
Public Health Service Act ,
Rulemaking Process ,
SCOTUS ,
Statutory Interpretation
In a monumental opinion issued today, the U.S. Supreme Court in Loper Bright Enterprises v. Raimondo overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., holding (6-3) that deference to an agency's...more
7/1/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Constitutional Challenges ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
National Marine Fisheries Service ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Stare Decisis ,
Statutory Interpretation ,
Unconstitutional Condition
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
5/28/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). This action...more
The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
On July 3, 2023, Senators Bernie Sanders (I-Vt.), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Bill Cassidy, M.D. (R-La.), Ranking Member of the HELP Committee, Bob Casey (D-Pa.), and Mitt...more
Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more