On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
9/5/2025
/ Administrative Procedure Act ,
Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
PHSA ,
Product Labels ,
Public Health ,
Regulatory Authority ,
Regulatory Oversight ,
Statutory Interpretation ,
Vaccinations
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more
7/9/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The US Supreme Court on June 28 decided Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, overruling the Chevron doctrine that for four decades has required federal courts to defer to...more
The US Supreme Court on June 28 decided Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, overruling the Chevron doctrine that for four decades has required federal courts to defer to...more