News & Insights Search

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Sai Bhamidipati, regulatory CMC director at Moderna.

US Food and Drug Administration (FDA) officials said the next iteration of the Medical Device User Fee Amendments (MDUFA VI) will focus on improvements in consistency during the review process and promoting domestic priorities, rather than pursuing shorter review timelines compared to MDUFA V.

The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation Network (QMIN), a cross-sector platform that uses quantitative medicine approaches to accelerate drug development and regulatory science and improve clinical decision-making.

Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS products and a draft guidance on assessing skin irritation using in vivo studies in TDS products.

A proposed amendment to 21 CFR Part 207 that eases registration rules for distributed manufacturers by allowing them to register as a single establishment could lead to a new paradigm where manufacturers shift their focus from product development to ensuring a product remains the same across multiple manufacturing sites.

The Therapeutic Goods Administration (TGA) has proposed adopting 11 international scientific guidelines for use in Australia.