Clinical Decision Support Software
This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as…
FDA Roundup: July 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: July 14, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: January 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Absolutely Natural – 715690 – 12/30/2025
CGMP/Finished Pharmaceuticals/Adulterated
Tower Laboratories Ltd. – 717456 – 12/23/2025
CGMP/Finished Pharmaceuticals/Adulterated
LiquidCapsule Manufacturing, LLC – 717069 – 12/19/2025
CGMP/Finished Pharmaceuticals/Adulterated
If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative
Washing your hands is one of the most important things you can do to avoid getting sick and spreading germs…
What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while…
FDA approves therapy for rare blood disorder in pediatric patients 12 years and older
The U.S. Food and Drug Administration approved Cablivi (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with…