Curriculum
- 6 Sections
- 29 Lessons
- 1 Day
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- U.S. Regulatory Landscape – The Big Picture Key Concepts5
- 1.1FDA centers (CDER, CBER, CDRH), regulatory jurisdiction, IND, IDE, NDA, BLA, PMA, 510(k)
- 1.2Total Product Lifecycle, Regulatory strategy, Risk-based classification
- 1.3Differences between drugs, biologics, devices, diagnostics, and combination products
- 1.4Example: A company failing due to choosing the wrong regulatory pathway
- 1.5Exercise: Map a sample product to its appropriate FDA center
- Regulatory Pathways for Medical Devices Core Pathways5
- 2.1510(k), De Novo, PMA, Breakthrough Device designation
- 2.2Substantial equivalence, Special 510(k), Real-World Evidence (RWE)
- 2.3How risk classification impacts regulatory route
- 2.4Example: Device cleared through De Novo that later scaled globally
- 2.5Classify a hypothetical device and decide its pathway
- Drug & Biologics Regulatory Pathways5
- 3.1Core Pathways: IND, NDA, ANDA, BLA.
- 3.2Keywords: “Orphan Drug”, “Fast Track”, “Accelerated Approval”, “Priority Review”.
- 3.3Nuances: Differences in small molecules vs biologics vs biosimilars.
- 3.4Real-Life Example: Biologic approved under expedited review with post-market commitments.
- 3.5Exercise: Draft a regulatory strategy for a biosimilar launch.
- Emerging Pathways & Expedited Programs4
- 4.1Focus: Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Accelerated Approval.
- 4.2Keywords: “Surrogate endpoints”, “Adaptive trial design”, “Real-World Data (RWD)”.
- 4.3Real-Life Example: COVID-19 EUA (Emergency Use Authorization) case.
- 4.4Exercise: Debate the pros & cons of seeking Breakthrough designation for a product.
- Compliance, Risk & Strategic Considerations5
- 5.1Key Concepts: Post-market surveillance, FDA inspections, labeling, advertising & promotion.
- 5.2Keywords: “Form 483”, “Warning Letter”, “cGMP”, “Good Clinical Practice (GCP)”.
- 5.3Nuances: How compliance failures impact approvals and market access.
- 5.4Real-Life Example: Market withdrawal due to post-market surveillance gaps.
- 5.5Exercise: Draft a corrective action response to a mock FDA inspection finding.
- Building a Regulatory Pathway Strategy5
- 6.1Scenario: US-based company developing an innovative combination product.
- 6.2Tasks: Select the appropriate FDA center & submission route.
- 6.3Incorporate expedited program options.
- 6.4Identify compliance risks and post-market obligations.
- 6.5Outcome: A practical, problem-solving framework for regulatory planning.