The following are some of the FDA Guidance documents that may be of interest
- Pharmacokinetics in patients with impaired renal function (pdf version)
- FDA News release communicated by ASN regarding updated FDA Guidance (pdf version)
- FDA Guidance on lupus nephritis (pdf version) was withdrawn and is being revised (see here)
- FDA Guidance on systemic lupus erythematosus drug development (pdf version)
- FDA Guidance on Fast Track Drug Development Programs (pdf version)
- FDA Guidance on Patient-Reported Outcome Measures (pdf version)
- FDA Guidance Guidance on Clinical Phamacogenomics, released Jan 2013 (pdf version)
- Guidance (E16) on Biomarkers in Drug Development (pdf versison)
- FDA Guidance on Adaptive Trial Designs (pdf version)