The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Edwards Lifesciences Corp. has scored an approval from the U.S. FDA for the Konect Resilia aortic valved conduit, a ready-to-implant solution for bio-Bentall procedures.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Telemedicine Association, Heraeus, Zimmer Biomet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical.
With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Computer Systems, Diacarta, Edwards, Huntleigh Healthcare, Icad, Paragon 28.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bayer, Kiniksa, Mallinckrodt, MC2, Merck, Redhill, Tetra, Tracon and Tricida.
While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment.
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