China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
To streamline the development of biosimilars and align it with current analytical science, regulators across the globe are reevaluating a routine requirement for comparative clinical efficacy studies for biosimilar candidates.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Arcutis, Biontech, Cygenica, Eikon, Gain, Hoth, Moderna, Pfizer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annalise.ai, Corvista.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
Instead of the bivalent COVID-19 vaccines comprising both the original and omicron BA.4/BA.5 SARS-CoV-2 strains that have been in use in the U.S. since April, the CDC’s Advisory Committee for Immunization Practices voted 13-1 Sept. 12 to recommend the universal use of updated monovalent XBB-containing COVID-19 vaccines as authorized or approved by the FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bicycle, Biolinerx, Biosyngen, Day One, Tango, Verona.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Limflow, Stryker Surgical, Zeta Surgical.
Limaca Medical Ltd. received U.S. FDA 510(k) clearance for its Precision for gastrointestinal (GI) endoscopic ultrasound (EUS) biopsy device which the company said allows for faster, more efficient and safer collection of tumor tissue samples. The approval follows the receipt of breakthrough device designation, and the deployment of the device into the U.S. market should lead to more efficient and effective diagnosis of GI cancers.
Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.
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