How Drugs Get Approved: What the FDA Does and Why It Matters to You (FDA, 2019)

Introduction:
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medications. Their process for approving new drugs is detailed and thorough, aimed at protecting patients while encouraging innovation.

Key Points for Patients:

  1. What Is the Approval Process?
    • It begins with laboratory research, often taking years of testing before a drug even reaches human trials.
    • Once safety in humans is established, the drug moves through three phases of clinical trials.
      • Phase 1: Tests for safety in a small group of people.
      • Phase 2: Focuses on efficacy and side effects.
      • Phase 3: Confirms effectiveness in larger populations and monitors adverse effects.
  2. The FDA’s Role:
    • After the trials, companies submit a New Drug Application (NDA), including all data collected.
    • The FDA reviews this data, inspecting manufacturing facilities and assessing labels for accuracy.
  3. Why This Matters to You:
    • The process ensures that drugs are effective and that risks are manageable before they reach your pharmacy.
    • While it’s thorough, some drugs receive priority review for serious conditions with no other treatments.

The VitalPoint for Patients:
Understanding how drugs are approved helps patients appreciate why treatments can take time and why they can trust FDA-approved medications. Always look for FDA approval when considering a new treatment.

Learn More:

VitalPoint Technologies, Inc.

Disclaimer

None of the statements in this announcement or via any web sites linked herein have been evaluated by the FDA. Furthermore, none of the statements in this announcement or any web sites linked herein should be construed as dispensing medical advice or making claims regarding the cure of diseases. You should consult a licensed health care professional before starting any supplement, dietary, or exercise program, especially if you are pregnant or have any pre-existing injuries or medical conditions. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any diseases.

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