Recently Posted Guidance Documents

Clinical - Medical 4/20/2018 Opioid Dependence: Developing Depot Buprenorphine Products for Treatment ICH-Quality 4/19/2018  Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry Electronic Submissions, Administrative / Procedural 4/19/2018  Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document Chemistry, Manufacturing, and Controls (CMC) 4/18/2018  Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations Physical Medicine Devices, Premarket 4/16/2018 Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff