The FDA’s safety and performance-based pathway for 510(k) devices promises to streamline premarket filings, and the FDA’s Jason Ryans said on a recent webinar that any changes to the related product-specific guidances would be applicable only prospectively. Ryan made no mention of a grace period for impending applications, however, suggesting that any such devices may have to be reworked or resubmitted into a more conventional premarket channel if they do not meet the new requirements.
Rochester, N.Y.-based Carestream Health Inc. has won the FDA’s nod for its Dual-Energy imaging technology and Focus 35C detector with Image Suite software. The company plans a global launch of the Focus 35C by the end of the year, with U.S. rollout of Dual-Energy early next year.
Less than four months after accepting Alnylam Pharmaceuticals Inc.'s NDA for Givlaari (givosiran), the FDA has approved the new RNAi therapy for the treatment of adults with the rare genetic disorder acute hepatic porphyria (AHP). The condition is defined by a buildup of toxic porphyrin molecules formed during the production of heme. That buildup can cause incidents of severe pain and paralysis, respiratory failure, seizures and mental status changes, according to the agency.
Stephen Hahn of the MD Anderson Cancer Center generally managed to avoid any controversy in the Nov. 20 Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) NDA for surufatinib as a treatment for patients with advanced non-pancreatic neuroendocrine tumors (NET) has been accepted for review by China’s National Medical Products Administration (NMPA).
The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently. The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs.
The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.