Digest: September 2025 Featured news that matters in medical writing and communications
The newsletter provides a summary of the recent news or key updates in the field of medical writing and relevant for our business activities. Information is selected from various sources such as the EMWA, AMWA, ICH, EMA, US FDA, and European Commission websites. We hope you find the newsletter informative!
EMA News
EMA revised the Procedural advice on paediatric applications (Rev. 14), together with the template for the key elements form (v8) (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-procedures).
The CTCG/EMA Frequently Asked Questions document (version 1, 12 May 2025) was published in July entitled ‘Frequently asked questions related to Clinical trials submitted under the Regulation EU 536/2014’. These FAQs were submitted to the EMA through different channels. They were addressed by the CTCG in collaboration with the European Medicines Agency Clinical Trials Systems and Clinical Trials Transformation workstreams (https://www.hma.eu/about-hma/working-groups/clinical-trials-coordination-group.html).
US FDA Drugs & Biologics News
The US FDA began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS), which is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers. The public can view the latest adverse event data on the FAERS Public Dashboard. For more information, refer to https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data.
The Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program, launched in 2020 to provide a pathway to “qualify” novel drug development tools (DDTs) that did not fit within the agency’s existing qualification programs, has transitioned to a permanent DDT Qualification Program. DDTs are methods, materials, or measures that may help with drug development and may include biomarkers like biological molecules that can signal a condition or disease, or clinical outcome assessments, which include measurements of a patient’s feelings, ability to function, and survival (https://www.fda.gov/news-events/fda-voices/fda-advances-drug-development-innovation-establishing-istand-permanent-qualification-program?utm_medium=email&utm_source=govdelivery).
ClinicalTrials.gov
A video on how to download study record data from ClinicalTrials.gov is available at https://www.nlm.nih.gov/oet/ed/ct/demo_videos.html.
TransCelerate
Transcelerate published a summary report of their discussions with the US FDA to advance the use of pragmatic trials, and a resource guide covering topics such as pragmatic trial design, operational implementation, data/results interpretation, regulatory considerations, and case study learnings (https://www.transceleratebiopharmainc.com/initiatives/embedded-pragmatic-clinical-trials/).
Transparency & Disclosure
The PHUSE Data Transparency Working Group developed the Good Transparency Practice (GTP) guideline, including best practices to govern anonymization of clinical trial data (https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-080.pdfhttps://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-080.pdf).
PHUSE published a white paper on ‘Rare Disease Clinical Data Sharing’ reviewing potential barriers to the sharing of rare disease data. Included are discussions around rare disease-specific considerations and recommendations (https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-095.pdf).
EU COMBINE
The EU COMBINE project was launched in June 2023 to address challenges encountered by sponsors when conducting combined studies that require application of Regulation (EU) 536/2014 (clinical trials on medicinal products for human use) together with Regulation (EU) 2017/745 (on medical devices) or 2017/746 (on in vitro diagnostic medical devices). As part of Project 1 within the COMBINE program, a pilot initiative was introduced to streamline the authorization process, reduce the administrative workload for sponsors, and accelerate patient access to innovative treatments (https://health.ec.europa.eu/medical-devices-topics-interest/combine-programme/combine-project-1-pilot-all-one-coordinated-assessment_en).
Medical Devices
The EU Medical Device Coordination Group (MDCG) released guidance document MDCG 2024-14 rev.1 Guidance on the implementation of the Master UDI-DI solution for contact lenses.
The US FDA published the final guidance document Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, which provides recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The FDA reviews the PCCP as part of a marketing submission for an AI-enabled device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.
EUDAMED
EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the 2 Medical Devices Regulations. The EUDAMED gradual roll out planning timeline (July 2025) is under review (https://health.ec.europa.eu/medical-devices-eudamed/overview_en).
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