Regulatory Affairs Professionals Society

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FDA on Tuesday issued draft guidance on submitting investigational device exemption applications electronically using the electronic Submission Template and Resource template.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FDA on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing products, including those that feature multiple product variants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

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