Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry | FDA

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry | FDA

Guidance Documents - Request for Comment

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry
This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD). This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry
This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381).

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer.

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
This guidance provides recommendations to sponsors regarding the development of drugs and biologics,  regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma.