FDA Guidance Documents

The following are some of the FDA Guidance documents that may be of interest

  1. Pharmacokinetics in patients with impaired renal function (pdf version)
  2. FDA News release communicated by ASN regarding updated FDA Guidance (pdf version)
  3. FDA Guidance on lupus nephritis (pdf version) was withdrawn and is being revised (see here)
  4. FDA Guidance on systemic lupus erythematosus drug development (pdf version)
  5. FDA Guidance on Fast Track Drug Development Programs (pdf version)
  6. FDA Guidance on Patient-Reported Outcome Measures (pdf   version)
  7. FDA Guidance Guidance on Clinical Phamacogenomics, released Jan 2013 (pdf version)
  8. Guidance (E16) on Biomarkers in Drug Development (pdf versison)
  9. FDA Guidance on Adaptive Trial Designs (pdf version)
  10. FDA Guidance on Regenerative Therapies (pdf version)

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