Agebox iKids Growth Day Formula may be harmful due to hidden ingredient
FDA laboratory analysis confirmed that Agebox iKids Growth Day Formula contains ibutamoren not listed on the product label.
SILINTAN may be harmful due to hidden drug ingredient
FDA laboratory analysis confirmed that SILINTAN contains meloxicam not listed on the product label.
FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary
FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary
FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary
Ralph A. DeFronzo, M.D./University of Texas Health Science Center at San Antonio – 716773 – 09/17/2025
Clinical Investigator/Sponsor
Janssen Vaccines Corp., A Johnson & Johnson Company – 713194 – 07/18/2025
CGMP/Finished Pharmaceuticals/Adulterated
cheaptrustedpharmacy.com – 705501 – 07/29/2025
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
motionpharmacy.com – 715595 – 09/10/2025
Unapproved New Drug/Misbranded
Real-World Evidence
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act,…
FDA use of Real-World Evidence in Regulatory Decision Making
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and…