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Back to SteamcellSCE Educational LibraryStructured Educational Evidence Review · Dr. Mack Sullivan

Category 13

FDA and International Regulation

10 topics planned. Each topic is published as a Professional and Patient edition only after explicit author approval.

  • 13.1U.S. regulatory foundations
    In preparation
    1. · Drugs
    2. · Biological products
    3. · Human cells and tissues
    4. · Public Health Service Act
    5. · Food, Drug, and Cosmetic Act
    6. · FDA/CBER oversight
  • 13.2HCT/P framework
    In preparation
    1. · Section 361 products
    2. · Section 351 products
    3. · Minimal manipulation
    4. · Homologous use
    5. · Systemic effect
    6. · Dependence on metabolic activity
  • 13.3Investigational New Drug applications
    In preparation
    1. · Preclinical package
    2. · Chemistry, manufacturing, and controls
    3. · Clinical protocol
    4. · Investigator qualifications
    5. · Safety reporting
    6. · FDA authorization to proceed
  • 13.4Marketing authorization
    In preparation
    1. · Biologics License Application
    2. · Evidence requirements
    3. · Facility inspection
    4. · Labeling
    5. · Postmarketing commitments
  • 13.5Expanded access
    In preparation
    1. · Individual-patient access
    2. · Intermediate-size populations
    3. · Treatment protocols
    4. · Eligibility
    5. · FDA and IRB roles
    6. · Cost recovery
  • 13.6Right-to-try laws
    In preparation
    1. · Eligibility
    2. · Differences from expanded access
    3. · Limitations
    4. · Manufacturer discretion
    5. · Financial risks
    6. · Data collection
  • 13.7Exosome regulation
    In preparation
    1. · Drug and biological-product classification
    2. · Investigational use
    3. · Manufacturing controls
    4. · Therapeutic claims
    5. · Unapproved commercial distribution
    6. · Research-use-only labeling
  • 13.8Advertising and enforcement
    In preparation
    1. · Disease-treatment claims
    2. · Misbranding
    3. · Warning letters
    4. · Injunctions
    5. · Product seizures
    6. · Registration versus approval
  • 13.9International regulation
    In preparation
    1. · European Union
    2. · United Kingdom
    3. · Canada
    4. · Australia
    5. · Japan
    6. · South Korea
    7. · China
    8. · Latin America
    9. · Regulatory-tourism concerns
  • 13.10Verifying regulatory status
    In preparation
    1. · FDA databases
    2. · Approved labeling
    3. · IND documentation
    4. · ClinicalTrials.gov
    5. · IRB information
    6. · Foreign regulatory authorities
    7. · Warning letters