5 Steps of FDA Approvals
 
                  5 Steps of FDA Approvals
The U.S. Food and Drug Administration (FDA) follows a structured process to ensure that drugs are safe, effective, and high-quality before they reach patients.
1. Preclinical Testing (Laboratory & Animal Studies)
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Conducted before human trials. 
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Purpose: Assess safety, toxicity, pharmacology, and efficacy signals. 
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Data generated is used to file an Investigational New Drug (IND) application with the FDA. 
2. Investigational New Drug (IND) Application
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Submitted to FDA before starting clinical trials. 
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Contains preclinical data, manufacturing details, and clinical trial protocols. 
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FDA reviews the IND (typically within 30 days) to ensure it is safe to proceed with human trials. 
3. Clinical Trials (Human Testing)
Divided into 3 phases:
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Phase I: Small group (20–100 healthy volunteers or patients). Focus on safety, dosage, and pharmacokinetics. 
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Phase II: Larger group (100–500 patients). Focus on efficacy and side effects. 
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Phase III: Large-scale studies (1,000+ patients). Confirm efficacy, monitor adverse effects, compare with standard treatments. 
If successful, sponsor files a New Drug Application (NDA) or Biologics License Application (BLA).
4. FDA Review of NDA/BLA
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FDA evaluates all submitted data: - 
Clinical trial results 
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Manufacturing and facility compliance (cGMP inspections) 
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Labeling (accuracy, clarity, safety info) 
 
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Expert advisory committees may be consulted. 
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Standard review: ~10 months; Priority review: ~6 months. 
5. FDA Post-Market Surveillance (Phase IV)
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After approval, FDA continues monitoring through: - 
MedWatch reports (adverse events) 
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Post-marketing studies (Phase IV commitments) 
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Inspections of manufacturing facilities 
 
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If risks outweigh benefits, FDA can issue label changes, restrictions, or product recalls. 
✅ Summary
The 5 steps of FDA approvals are:
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Preclinical Testing 
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IND Application 
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Clinical Trials (Phases I–III) 
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FDA Review of NDA/BLA 
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Post-Market Surveillance (Phase IV) 
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