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

FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices requirements, and to a research laboratory for failing to comply with good laboratory practices. hubs.la/Q04BnFgM0

A new initiative from FDA aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases, according to a 14 October announcement from the agency. hubs.la/Q04BnC390

Congress should enact a specific regulatory framework for artificial intelligence models developed and used in academic medical centers, Scott Gottlieb argued in an opinion piece published in JAMA Health Forum. hubs.la/Q04BnzsJ0

The UK Medicines and Healthcare products Regulatory Agency has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence and personalized medicine. hubs.la/Q04BgjRK0

Stakeholders are urging FDA to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder and post-traumatic stress disorder. hubs.la/Q04BgczL0

Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the Journal of Pharmaceutical Sciences. hubs.la/Q04B68bk0

The number of clinical trials authorized in the EU and European Economic Area has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research. hubs.la/Q04z-_Xp0

FDA last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address manufacturing changes for interchangeable products. hubs.la/Q04z--SZ0

Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by FDA, with a majority of the increase linked to the use of non-primary patents. hubs.la/Q04zT_Gx0

FDA recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. hubs.la/Q04zKsBK0

The European Medicines Agency's Committee for Medicinal Products for Human Use is planning to update a 2018 guideline on good pharmacogenomic practices. hubs.la/Q04zBkY50

The Medicines and Healthcare products Regulatory Agency says the UK government has adopted a list of recommendations on the use of artificial intelligence in medical devices developed by an independent group of doctors in the National Health Service. hubs.la/Q04zrlVd0

The World Health Organization has issued an updated draft guideline to assist manufacturers establish an effective quality risk management system and to help regulators in planning their inspections. hubs.la/Q04zrj_n0

FDA Office of Prescription Drug Promotion has issued an untitled letter to Evolus for exaggerating efficacy claims for its drug Jeuveau and for “blurring the lines” between prescription products and consumer cosmetics on Instagram. hubs.la/Q04zg8tF0