Pregnant? Breastfeeding? FDA Aims to Improve Drug Information
The FDA is helping women know more about the effects of medicines during pregnancy and breastfeeding. Discuss treatment options with…
Ingesting or Inhaling Nitrite “Poppers” Can Cause Severe Injury or Death
Health care providers report increase in hospitalizations and deaths due to nitrite popper ingestion or inhalation.
Gerber Products Company Announces Recall and Discontinuation of All Batches of Gerber® Soothe N Chew® Teething Sticks Due To Choking Hazard
January 31, 2025 — Gerber Products Company is initiating a recall and discontinuation of all batches of GERBER® SOOTHE N…
Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and…
S7A Safety Pharmacology Studies for Human Pharmaceuticals
International Council on Harmonisation – Safety
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
Guidance for Industry – Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format,…
