Recently Posted Guidance Documents on Clinical - Medical; Combination Products; Chemistry, Manufacturing, and Controls (CMC)

Clinical - Medical 2/15/2018 Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older 2/15/2018 Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry 2/15/2018 Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment 2/15/2018 Migraine: Developing Drugs for Acute Treatment 2/12/2018 Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry Combination Products 2/14/2018 How to Prepare a Pre-Request for Designation (Pre-RFD) Chemistry, Manufacturing, and Controls (CMC) 2/14/2018 Regulatory Classification of Pharmaceutical Co-Crystals Guidance Document Search Search all FDA official guidance documents and other regulatory guidance