IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
EMA Launches Early Scientific Advice Program for High-Risk Medical Devices
The European Medicines Agency (EMA) has launched a new Early Scientific Advice (ESA) program aimed at supporting the development of high-risk medical devices. This initiative seeks to provide manufacturers with timely regulatory guidance, ensuring that innovative medical technologies meet the necessary safety and efficacy standards before reaching the market.
Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
US FDA releases 5 New Over the Counter (OTC) Monographs (final orders)
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.
FDA Approves Free Sale of OTC Hearing Aids
In August 2022, the FDA finalizes the historic rule allowing millions of Americans access to over-the-counter hearing aids.
US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
The US-FDA Launches New Reportable Food Registry (RFP)
On January 5, 2022, The FDA published a new, interactive public data dashboard that allows anyone to view historical data from the Reportable Food Registry (RFR).
The US FDA deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.