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Phase 1 · Weeks 1–12

Foundation Curriculum

Twelve weeks of structured study covering every regulatory body, document and convention a medical writer needs to know. Real resources. Practical tasks. Interview-ready by Week 12.

Your progress0/12 weeks
Phase 01 · Regulatory BodiesWeek 13h study

FDA: structure, remit and the drug approval pathway

By the end of this week you will

  • 01Understand CDER, CBER, CDRH and what each regulates
  • 02Map the IND → Phase I/II/III → NDA → approval arc
  • 03Know the difference between NDA, BLA and 505(b)(2)
  • 04Understand what an IND application contains and who writes it

Resources — in order of priority

  1. VideoDrug Approval Process in USA & EU — Step-by-Step

    Covers the full FDA and EMA pathway side-by-side. Watch this first. (~15 min)

  2. VideoFDA: Overview of Our Role Regulating Drugs (official video series)

    Short official FDA videos walking through the approval process. Watch all four parts.

  3. ArticleFDA: Development & Approval Process for Drugs

    The definitive FDA page. Read the 'How Drugs Are Developed and Approved' section in full.

  4. ArticleFDAReview.org: The Drug Development and Approval Process

    Clear independent explainer with phase-by-phase breakdown.

  5. Official docFDA Drug Approval Process Infographic (PDF)

    Download and keep this. A one-page visual map of the whole pathway.

Practical task before moving on

Draw the drug development pathway from preclinical to post-approval on paper — from memory, without looking. Label every key decision point and the documents filed at each stage. Check against the FDA infographic. Any gaps = re-read that section.

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