Recently Posted Guidance Documents

Recently Posted Guidance Documents

Devices 9/6/2018  Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff Drugs 9/5/2018 Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry 9/5/2018 Nonallergic Rhinitis: Developing Drug Products for Treatment 9/4/2018 Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry