Recently Posted Guidance Documents

Recently Posted Guidance Documents

• 9/6/2019 - Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff
• 9/5/2019 - Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry
• 9/5/2019 - Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff
• 9/4/2019 - Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers