How the FDA Ensures Drug Safety – From Lab to Approval
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How the FDA Ensures Drug Safety – From Lab to Approval
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Title: How the FDA Ensures Drug Safety – From Lab to Approval
Episode Summary: Ever wondered how the FDA makes sure every medication is safe and effective before it reaches your pharmacy shelf? In this episode of Talking in the Woods – Science Behind the Script, host Christopher Wood takes you behind the scenes of drug development—from early lab studies to full FDA approval.
What You’ll Learn in This Episode:
- The preclinical phase: in vitro and in vivo testing, genotoxicity, and pharmacokinetics
- Clinical trial phases: What happens in Phase I, II, and III
- NDA vs BLA: What these regulatory terms mean and why they matter
- FDA review timelines: Standard vs Breakthrough Therapy designation
- Safety reporting and labeling, including the infamous black box warning
🎧 Listen now to understand the science behind safer medicines.
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