Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating medical devices to ensure their safety and effectiveness. One area of growing importance is the remanufacturing of medical devices. The FDA’s guidance document, “Remanufacturing of Medical Devices,” provides essential recommendations for distinguishing between servicing and remanufacturing activities to maintain device integrity and […]
Container Closure System and Component Changes: Glass Vials and Stoppers
The U.S. Food and Drug Administration (FDA) has released guidance on Clinical Decision Support (CDS) software, which aims to clarify regulatory oversight and ensure the safety and effectiveness of such tools in healthcare. The guidance document, titled “Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff,” outlines the criteria for determining […]
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 […]
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability
In November 2024, the U.S. Food and Drug Administration (FDA) issued a guidance document titled “Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development.” This guidance aims to assist sponsors in incorporating circulating tumor DNA (ctDNA) as a biomarker in early-stage solid tumor clinical trials conducted under investigational new drug applications (INDs) and […]
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
Introduction The U.S. Food and Drug Administration (FDA) has released a new guidance document titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance, issued in November 2024, aims to help manufacturers transition sterilization facilities while ensuring continued availability of critical medical devices. Given the growing regulatory scrutiny on […]
Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions
Understanding the FDA Guidance on Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Introduction The U.S. Food and Drug Administration (FDA) has released a crucial guidance document addressing the acceptable intake (AI) limits for nitrosamine drug substance-related impurities (NDSRIs). Given the rising concerns regarding nitrosamine contamination in pharmaceutical products, this guidance provides regulatory clarity […]
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
The U.S. Food and Drug Administration (FDA) has provided comprehensive guidance on adaptive designs for clinical trials in the development of drugs and biologics. This document, titled Adaptive Designs for Clinical Trials of Drugs and Biologics, offers a framework for pharmaceutical companies and researchers to implement adaptive trial designs while ensuring scientific validity and regulatory […]