Before any drug can be sold in the United States, it must be approved by the U.S. Food and Drug Administration (FDA). This is true whether it's a prescription or an over-the-counter drug. The FDA evaluates both the effectiveness and safety of a drug by looking at:
- How animal testing and human clinical trials affect the condition the drug is treating
- If any side effects occur
- How it's manufactured
- What the labeling says
The FDA also monitors a drug's safety after approval. Health care providers and patients can report drug side effects through the FDA's MedWatch website.
For you, drug safety means buying online only from licensed pharmacies located in the United States. It also means knowing how to take your medicines correctly.
- Drug Development Process (Food and Drug Administration)
- Is It Legal for Me to Personally Import Drugs? (Food and Drug Administration) Also in Spanish
- Is It Really FDA Approved? (Food and Drug Administration) Also in Spanish
- MedWatch, the FDA Safety Information and Adverse Event Reporting Program (Food and Drug Administration)
- Postmarket Drug Safety Information for Patients and Providers (Food and Drug Administration)
- Recalls, Market Withdrawals and Safety Alerts (Food and Drug Administration)
- 10 Facts about What FDA Does and Does Not Approve (Food and Drug Administration) Also in Spanish
- Generic Drugs Undergo Rigorous FDA Review (Food and Drug Administration)
- Generic Drugs: Questions & Answers (Food and Drug Administration)
- How to Buy Medicines Safely from an Online Pharmacy (Food and Drug Administration) Also in Spanish
- Quick Tips for Buying Medicines Over the Internet (Food and Drug Administration) Also in Spanish
Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)
- Article: Methodological guidelines and publications of benefit-risk assessment for health technology assessment:...
- Article: Expanding regulatory science: Regulatory complementarity and reliance.
- Article: Sudden Spurt in Pediatric Patients with AKI in Uzbekistan: A Call...
- Drug Safety -- see more articles