Search functions on online sources were used when available, using terms such as “unmet medical need,”“unmet need,” or “therapeutic need” alone and in combination with “definition.” Additionally, these terms were put into Google together with the name of the stakeholder or institute to ...
FDA Announces Availability of the Final Guidance for Expedited Access to Devices Intended for Unmet Medical NeedsGladstein, Lana
Therefore, efforts in early recognition and treatment have largely fallen short of addressing this dramatically unmet medical need. Physiological basis of osteoporosis in men Bone is continuously under a dynamic metabolic equilibrium by the parallel action of bone-resorbing osteoclasts and bone producing ...
“The highest unmet medical need is platinum-resistant recurrent ovarian cancer,” Monk said. “In fact, since the FDA approval of bevacizumab [Avastin] in 2014, we have no new agents. We need to continue to push in both platinum-sensitive and platinum-recurrent disease, but pl...
2023 is a banner year for patients with PMR. After a 6-decade wait, they have a new treatment option – the IL-6 receptor antagonist sarilumab. The pharmaceutical industry has awakened to their enduring unmet medical need, which even with the approval of sarilumab remains substantial. An...
(95% CI: 0.41–0.97),P = 0.033], but it did not have this effect throughout the follow-up period (mean: 26.2 months) [84]. No treatment significantly reduced the CV death risk, regardless of the definition used. Most RCTs analyzed subgroups based on demographics, medical history, ...
Further large-scale studies that validate the findings from early stereotactic ablative radiotherapy trials and enable a more accurate definition of oligometastatic prostate cancer and determine the best treatment strategy (research need 10; LAC score 4) was very highly prioritized by the LAC. Advanced...
FDA Proposes New Expedited Access Program for Premarket Approval Med Devices Addressing Unmet Medical NeedsDooley, Kathleen
FDA Proposes Expedited Approval Program for PMA Medical Devices for Unmet NeedsTyler, Lynn
In part I, we introduce a summary on pediatric acute myeloid leukemia (AML) and the challenges related to its medical need. In part II, we present the PedAL/EuPAL collaboration, part of the Leukemia and Lymphoma Society’s “Dare to Dream” project. We further explain its aim and content...