Medical Design & Outsourcing

FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices

RAPID could enable Medicare coverage and payment as soon as two months after FDA approval, compared to a year or more with ...
Seeking Alpha

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
JD Supra

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under the Accelerated Approval Program. The 22-page guidance ...
BioSpace

Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions

Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute ...

US FDA's accelerated approval for drugs needs more transparency, says research firm

By Sneha S K April 16 (Reuters) - The U.S. Food and Drug Administration should be more transparent when granting accelerated ...
STAT

Bashing accelerated approval isn’t supported by the data

The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall ...

Addressing the Radiology Workforce Crisis Through Accelerated Education Pathways

By combining online academics with clinical simulation, a nationwide initiative is removing bottlenecks in radiologic ...