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…
FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products)…
Publications from Office of Biostatistics Staff
Publications from Office of Biostatistics Staff
Malaria: Developing Drugs for Treatment
Malaria: Developing Drugs for Treatment
FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
The U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome,…
Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health…