Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” . The FDA guidance provides recommendations for sponsors, clinical investigators, and Institutional Review Boards (IRBs) on defining, identifying, and reporting protocol deviations in clinical investigations. While FDA regulations do not explicitly define protocol deviations or classify […]
European Commission’s Guidance for Joint Clinical Assessments
In an effort to streamline and enhance the evaluation of health technologies across Europe, the European Commission has released a comprehensive guide focused on the validity of studies for joint clinical assessments (JCAs). This initiative, rolled out under the EU Health Technology Assessment Regulation (HTAR), represents a significant step toward harmonizing the assessment of new […]
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
The FDA has issued a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance outlines the agency’s policy regarding sterilization site changes for Class III medical devices sterilized using ethylene oxide (EtO). It is intended to address potential or actual disruptions at sterilization facilities that may […]
The Status of Use-Related Risk Analysis
Recently, a coalition of industry groups has made a strong call for revisions to the U.S. Food and Drug Administration’s (FDA) guidance on use-related risk analyses (URRA). This plea for change underscores growing concerns about the practical implications of the current guidelines and their impact on the development and approval of medical devices. The Current […]
US Regulation of Ingestible Medical Devices
Ingestible medical devices are at the forefront of innovation in healthcare, offering unique solutions for monitoring patient health and delivering therapies. These devices, which can be swallowed and often operate within the gastrointestinal tract, range from capsule endoscopes to drug delivery systems. As their use expands, understanding the regulatory framework governing these technologies in the […]
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The FDA has released final guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” This document offers updated recommendations for sponsors, clinical investigators, institutional review boards, contract research organizations, and other stakeholders on using electronic systems, records, and signatures in clinical trials involving foods, medical products, tobacco products, and […]
EMA Launches a Pilot Program on Orphan Medical Devices
In a significant move to address a critical gap in the healthcare industry, a new pilot program has been launched to support orphan medical devices. On August 2, 2024, the European Medicines Agency (EMA) announced that its effort, as mandated under Regulation (EU) 2022/123 (Regulation – 2022/123 – EN – EUR-Lex (europa.eu)), aims to provide […]
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 […]
EMA’s New Guideline on Therapeutic Equivalence in Nasal Products
The European Medicines Agency (EMA) is poised to introduce a new guideline aimed at establishing more robust comparative data to support therapeutic equivalence (TE) for nasal products to address gaps in the current framework. Therapeutic equivalence refers to the concept where two drugs or drug products are considered interchangeable if they are expected to have […]
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 […]
