Agency plans new guidance in traceability, REMS and biosimilarity, among others
Just before the snows shut down Washington last weekend, FDA issued its annual list of intended guidance documents across the range of regulatory functions it oversees. Some of these come about through legislation; some are agency-generated when a gap in FDA policies is realized. The agency strives to meet its schedule—under transparency recommendations from former Administrator Margaret Hamburg—but the deadlines get missed, and the guidances that are issued are sometimes not quite what was expected. Guidances are not “law;” but FDA promulgates these documents with the expectation that the goals they define will be met in one or another fashion.
At any rate, the 102 intended guidances range from major industry practices to specialized therapeutic areas. Some of the highlights:
It’s going to be a busy year.
LogiPharma Unpacked: Highlights, Key Insights, and the Road to 2025
October 16th 2024In this special post-show episode, we sit down with Ryan Portela, Head of Production for LogiPharma, to reflect on the highlights and key takeaways from this year’s event. From attendee feedback to the most impactful sessions, Ryan shares insider insights and discusses how the momentum from 2024 will continue to shape the future of pharma supply chains. Plus, get a sneak peek into the exciting plans for LogiPharma's 20th Anniversary in 2025.
Boosting Patient Adherence: The Power of Clinical Support Programs
October 3rd 2024In this podcast, we speak with Amanda Scholz, UBC Senior Clinical Program Manager, MHA, BSN, RN as we discuss the important role that clinical adherence programs play in empowering patients and bolster persistence to prescribed life-changing medications throughout their journey.