The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.

A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DOJ arraigns test maker for investor fraud.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beroni Group, Canon Medical, Scone Medical Solutions.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Advanced Ultrasound Systems, Ams, Beckman Coulter, Biospyder, Decision Diagnostics, Dynamic Engineering and Automation Group, Edwards Lifesciences, Endra Life Sciences, GE Healthcare, Guided Therapeutics, H Robotics, Harmonic Bionics, Highlife, Ii Ventures, Motility Medical, Neusoft Medical Systems, Newmars Technologies, Novacyte, Olympus, Peijia Medical, Precision Biomonitoring, Profound Medical, Q² Solutions, Sifi, Sun Genomics, Valgen Medtech, Votis Subdermal Imaging Technologies.

Keeping you up to date on recent developments in cardiology, including: Biomarkers can forecast the development of incident heart failure; Mouse model helps researchers find MAARS lncRNA; Heart disease deaths rise in age of COVID-19.

The latest global regulatory news, changes and updates affecting biopharma, including: EMA updates on cyberattack; CDSCO extends import leniency; FDA’s obsolete human tissue rule on scrapheap.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmune, Aim Immunotech, Anixa, Aptorum, Bioinvent, Biontech, Janssen, Jazz, Legend, Lumosa, Merz, Moebius, Myovant, Pfizer, Sesen, Taysha, Transgene, Viiv, Zogenix.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera Advanced Neural, AGC, Allecra, Alloy, Astrea, Biovaxys, Cannabics, Catalent, Dcprime, Evotec, Eyegate, Fox Chase, Gamma, GSK, Hasten, Hitgen, Icagen, Immunicum, Immunitybio, Ligand, Lilly, Mediwound, Merck & Co., Meters, Mydecine, Nantkwest Panoptes, Neuropathix, Novan, Nuvo, Nyrada, PDS, Pharmather, Pierre Fabre, Regenacy, Revive, Shanghai Haini, Shionogi, Takeda, Teijin, Transthera.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annexon, Athersys, Atyr, Azura, Biocryst, Bioeclipse, Biomarin, Clovis, Enlivex, Exelixis, Immunitybio, Inotrem, Mustang, Neurana, Oric, Regenacy, Roche, Sellas, Sirnaomics.