pharmaphorum3d
A new fast track for NHS access - good news for niche innovators
This accelerated pathway for new drugs and therapies ... Intelligence and learnings from the delivery of the early and managed patient access schemes will be used to better understand impact ...
JD Supra15d
FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law ...
PharmExec7d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
pharmaphorum2d
The UK pharma market – Accelerating Access or still stuck in the slow lane?
"My view is that the changes in access arrangements during the next year offer a unique opportunity to develop a collaborative, collective, accelerated patient access system," McFarlane told the ...
The American Journal of Managed Care23d
Price Caps During Accelerated Approval Would Help Address Financial Toxicity for Patients, Jensen Says
addressed challenges with the current accelerated approval pathway, which was created in 1992 to offer patients a way to gain access to novel therapies ahead of final results of a phase 3 trial.