First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

The Centers for Medicare and Medicaid Services has agreed to provide national Medicare coverage for mitral valve transcatheter edge-to-edge repair under a new coverage with evidence development policy. See what Neil Moat, chief medical officer for Abbott’s structural heart business, said about it here.

South Korea’s Ministry of Food and Drug Safety and Taiwan’s Food and Drug Administration will transition from ICCR observers to full members, joining regulatory authorities from the US, Europe, Japan, Canada and Brazil. PCPC’s Francine Lamoriello, EVP of global affairs, discusses.