Revised User Fees Guidance on for Combination Products
The U.S. Food and Drug Administration (FDA) has issued its final guidance on user fees for combination products. This new guidance released in July 2024 replaces the previous version from April 2005 and is set to further streamline the regulatory process for combination products. The move is aimed at clarifying the user fee structure and […]
Guidance for Essential Drug Delivery Outputs for Devices
The draft guidance document titled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products” released by the FDA in June 2024 provides industry stakeholders with key recommendations on essential drug delivery outputs (EDDOs) for drug delivery devices and combination products. EDDOs are critical to the design process and essential in ensuring […]
Developing Diversity Action Plans within Underrepresented Populations
The FDA’s draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines the agency’s expectations for sponsors of clinical studies involving drugs, biological products, and devices. The primary goal of this guidance is to enhance the inclusion of underrepresented populations in clinical research, ensuring that study findings […]
Draft Guidance on Use-Related Risk Analysis for Combination Products
In a significant move aimed at enhancing the safety and effectiveness of combination products, the U.S. Food and Drug Administration (FDA) has recently released a draft guidance document focusing on the use-related risk analysis (URRA) for these complex products. This draft guidance represents a crucial step in refining regulatory practices and ensuring that combination products—those […]
CDER Emerging Drug Safety Technology Program
The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence (AI) and emerging technologies within pharmacovigilance (PV) to advance drug safety and lifecycle management. This program fosters communication with the pharmaceutical industry to enhance the FDA’s understanding of AI-enabled tools and other technologies in PV, aiming to assess their performance, […]
ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs
In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first lawsuit in an attempt to block the implementation of the Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs). The contentious Final Rule, which aims to regulate LDTs, has sparked heated debates within the healthcare and regulatory […]
Regulatory Science Tools Catalog
On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, […]
FDA Issues Remanufacturing Guidance
On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on […]
FDA Issues Final Rule on Laboratory Developed Tests
the FDA clarified that In vitro Diagnostic Devices (IVDs), including Laboratory Developed Tests (LDTs), are regulated as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when manufactured by laboratories. This move aims to enhance patient safety by phasing out enforcement discretion for most LDTs over four years, aligning requirements for IVDs regardless of where they are made.
CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices
FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. The Chemicals List for Analytical Performance (CLAP) tool is chemical dataset intended to help analytical laboratories demonstrate their ability […]
