Category: American
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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…
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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…
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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…
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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…
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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety of medical products, including drugs, biologics, and medical devices. One of the key aspects of this responsibility is adverse event reporting, which helps identify potential risks and enhances patient safety. The FDA guidance document titled “Postmarketing Adverse Event Reporting for…
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Study Data Technical Conformance Guide – Technical Specifications Document
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring that drugs and biologics brought to market are both safe and effective. The agency’s guidance document, “Benefit-Risk Assessment for New Drug and Biological Products,” provides valuable insights into how regulatory decisions are made. This guidance, published to improve transparency, offers sponsors a…
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M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. One of its key areas of focus is safety signal management, which involves identifying, assessing, and mitigating risks associated with medicinal products. The FDA’s recent guidance document, “Safety Signal Management in Pharmacovigilance”, provides a structured…
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Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
The U.S. Food and Drug Administration (FDA) has issued a guidance document titled “Computer Software Assurance for Production and Quality System Software,” aimed at modernizing the approach to software validation within the medical device industry. This guidance provides recommendations on risk-based assurance activities for computer software used in production and quality systems, aligning with FDA’s…
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Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (FDA) has released an essential guidance document titled “Postmarketing Safety Reporting for Combination Products.” This guidance provides clarity on regulatory expectations for manufacturers and applicants of combination products, ensuring patient safety through structured postmarketing safety reporting (PMSR). What Are Combination Products? Combination products integrate two or more regulated components…