Regulatory Affairs Professionals Society

FDA on Monday finalized guidance to assist manufacturers in validating in vitro diagnostic devices that test for emerging pathogens during public health emergencies. hubs.la/Q04DSBsC0

A FDA official stated that the midterm congressional election results will not likely impact the reauthorization of the agency’s user fee agreements, which have been negotiated for FY 2028-2032. hubs.la/Q04Dzg_L0

As artificial intelligence (AI) permeates the regulatory world, experts said it won't take over regulatory professionals' jobs but will instead help them work more efficiently and dedicate more time on human interactions. hubs.la/Q04DqZ6G0

Sarah Yim, director of the FDA Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively working to help sponsors reduce their reliance on clinical efficacy studies. hubs.la/Q04Dq0Pl0

A top US FDA enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the previous year. hubs.la/Q04DfkBZ0

More than 500 comments have been submitted in response to the FDA discussion paper on generative AI (genAI)-enabled medical devices, and stakeholders have offered the agency a wide variety of advice on the best way to regulate these technologies. hubs.la/Q04DfhV70

Patients who reviewed and signed a patient agreement form (PAF) for mifepristone and misoprostol under the FDA risk evaluation and mitigation strategy program were equally knowledgeable about medication abortion. hubs.la/Q04D4Nc_0

FDA issued revised draft guidance on Thursday aimed at assisting sponsors of drug-device combination products in designing and developing essential drug delivery device performance characteristics for their products. hubs.la/Q04C-kj80

The Department of Health and Human Services has announced that it will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug substances. hubs.la/Q04CSkrv0

FDA on Tuesday issued draft guidance on submitting investigational device exemption applications electronically using the electronic Submission Template and Resource template. Joanne Eglovitch reports for Regulatory Focus: hubs.la/Q04CKYq10

An expert and officials from FDA offered tips for de novo classification requests and reviewed some of the changes related to de novos being proposed under the Medical Device User Fee Amendments (MDUFA VI) program at The MedTech Conference last week. hubs.la/Q04CzrDS0

FDA on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing products, including those that feature multiple product variants developed under a single investigational new drug application. hubs.la/Q04Czr130

Acting US FDA Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease development and incorporating the patient voice into scientific reviews for orphan therapies. hubs.la/Q04Cs3330

There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence to support the marketing of medical devices, according to experts who spoke at The MedTech Conference on Monday. hubs.la/Q04CgKvh0

Major pharmaceutical companies are urging the FDA to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems for drugs and biological products, especially when established materials and technologies are used. hubs.la/Q04C7mhF0

Top FDA medical device officials said they are focused on restaffing after last year’s reduction-in-force and are optimistic about the Medical Device User Fee Amendments agreement during a town hall panel at The MedTech Conference. hubs.la/Q04C7g4r0

Regulators from the US and UK discussed ongoing efforts to develop regulatory frameworks that are better suited to generative artificial intelligence products at The MedTech Conference on Tuesday. hubs.ly/Q04BWMn80

FDA on Tuesday finalized guidance to address how sponsors can develop, distribute, and label software applications used alongside prescription medicines. hubs.la/Q04BS-lx0

Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation, according to a top industry executive who spoke at The MedTech Conference on Monday. hubs.la/Q04BJF8z0

More than a third of FDA Center for Drug Evaluation and Research drug advisory committee meetings held between 2013 and 2022 included a patient or consumer representative belonging to an advocacy organization that received industry funding. hubs.la/Q04BxBRG0