The US Food and Drug Administration is consolidating key functions, updating reporting structures, and formalizing realignment to improve coordination.
FDA
FDA issues multiple July 7 warnings over unauthorized ketamine products
Quick Read
Premium
A series of FDA warning letters flagged several injectable keratin hair‑straightening products for lacking required authorization.
The FDA’s rule would simplify registration for DMEs and heighten visibility for foreign drug supply sources.
As Anthropic pushes deeper into life sciences, the FDA is sharpening rules around AI‑enabled research and the use of computational predictions in regulated development pipelines.
The pilot cohort selected for the PreCheck will test early facility reviews aimed at boosting US pharmaceutical manufacturing capacity and strengthening the domestic drug supply chain.
Regulatory experts say the pattern signals that heightened scrutiny of drug advertising under the Trump administration is likely to continue.
America’s early-stage clinical trials have increasingly moved overseas, raising concerns about the nation’s long-term competitiveness in biomedical innovation.
Regulator says that warnings about the safety and effectiveness of testosterone replacement therapy should be removed from labels.