Food and drug administration

General
1

FDA

FDA = Food and Drug Administration (USA)
It approves and controls drugs, vaccines, medical devices, and food safety in the USA.

FDA regulatory areas
FDA regulatory areas1024×1536 281 KB

FDA Guidelines:

1) GMP (Good Manufacturing Practices)
Purpose: Ensure medicines are made safely and consistently.
FDA GMP is mainly under:

  1. 21 CFR Part 210 (General GMP)
  2. 21 CFR Part 211 (Finished Pharmaceuticals)
    Key points:
  • Clean manufacturing area
  • Trained staff
  • Proper equipment validation
  • Batch records
  • Quality control testing
  • Handling deviations and CAPA
    2) Drug Approval Process (FDA)
    FDA approval is based on clinical evidence.
    Main steps:
  • Preclinical (animal/lab testing)
  • IND (Investigational New Drug) application
  • Clinical Trials (Phase 1, 2, 3)
  • NDA / BLA submission
    NDA = New Drug Application
    BLA = Biologics License Application
    Post marketing monitoring
    3) FDA GCP (Good Clinical Practice)
    Purpose: Protect patient safety and ensure proper trial data.
    Covered under:
    ICH-GCP + FDA regulations like 21 CFR Part 50, 56, 312
    4) Labeling Guidelines
    FDA controls drug labeling under:
    21 CFR Part 201 Includes:
  • Indications
  • Dosage
  • Side effects
  • Warnings
  • Contraindications
  • 5) Pharmacovigilance (Safety Reporting)
    FDA safety reporting:
    FAERS (FDA Adverse Event Reporting System)
    Mandatory reporting for serious adverse events

MBH/PS