<속보>(기사 작성중) 카프리코(Capricor), “FDA가 데라미오셀(Deramiocel)의 심사 완료일을 3개월 늦췄다”(The FDA delayed the completion of the review for Deramiocel by three months)고 발표… 논란 속 기한 연장이 데라미오셀을 살려 낼까?
2026-08-27
Finally, a Path Forward? Bridging the Gap between FDA Authorization and Medicare Reimbursement – RAPID Program.
FDA recently announced Regulatory Alignment for Predictable and Immediate Device (“RAPID”) program. RAPID is intended to address a persistent barrier to bringing innovative medical devices to market: delays in obtaining insurance coverage following FDA authorization. In the past, this delay occurred because the Centers for Medicare and Medicaid Services[Read More…]
