Recently Posted Guidance Documents

Drugs

2/6/2019  Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry

2/6/2019  Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment

Devices

2/8/2019  Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff

2/5/2019  The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff

Combination Products, Premarket

2/6/2019  Principles of Premarket Pathways for Combination Products