11/19/2023 0 Comments Orbis clinical drug safety![]() ![]() ![]() Accordingly, reductions in drug development and approval timelines have been shown to create substantial improvements in patient lifespan and quality of life (Pharmaceutical Research and Manufacturers of America (PhRMA) 2022). Efforts have been made, globally, by the pharmaceutical industry and health authorities to reduce drug development timelines to expedite access to new drugs. Within the past decade, clinical development processes for innovator products have taken an average of 9.1 years to advance from initial clinical development to marketing approval in the USA (Brown et al. ![]() For many complex and serious disease states, patients are adversely impacted by long development timelines that impede the availability of new drugs. Patients with critical illnesses around the world rely on timely access to safe and effective therapeutics. As RTOR, Project Orbis, and PQAAid are relatively new initiatives, the experiences shared by the panel experts are valuable for providing deeper insight into these new regulatory pathways and processes. Key topics included managing cross-regional regulatory CMC requirements, adapting to expedited development timelines, coordinating interactions between health authorities and industry, and potential opportunities for future improvement and expansion of these programs. Both panel sessions included representatives from the US Food and Drug Administration (FDA) and subject matter experts from the pharmaceutical and biotechnology industries, with the aim of facilitating knowledge sharing on CMC-specific advantages, challenges, eligibility criteria for participation, and operational modifications instituted through the utilization of these acceleration initiatives. The panel sessions were held on August 27, 2021, for the discussion of RTOR, and January 21, 2022, for the discussion of Project Orbis and the PQAAid. The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). ![]()
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