Application User Fees for Combination Products
The U.S. Food and Drug Administration (FDA) provides detailed guidelines for the use of Investigational Device Exemptions (IDE) in early feasibility studies (EFS) to support medical device innovation. The guidance document, “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including First-in-Human (FIH) Studies,” outlines the requirements and regulatory pathways for conducting these […]
Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older
The U.S. Food and Drug Administration (FDA) has issued guidance titled “Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older.” This document provides recommendations for sponsors on the clinical development of drugs aimed at treating partial onset seizures (POS) in pediatric patients, […]
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The U.S. Food and Drug Administration (FDA) has released a guidance document titled “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder,” aimed at assisting industry and FDA staff in designing pivotal clinical studies for medical devices intended to treat Opioid Use Disorder (OUD). U.S. Food and Drug Administration+1U.S. Food and Drug […]
