The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1health.io, Aseptiscope, Becton, Dickinson and Co., Butterfield Engineering, Certtech, China Grand Pharmaceutical and Healthcare Holdings, Dante Labs, Drawbridge Health, Exagen, Fluidigm, Healthcare Merger Corp., Heraeus Medical Components, Hologic, Hygea, Implantica, Lidco, Masimo, Mimedx, Parexel, Polarityte, Poseida Therapeutics, Pulse Systems, Soc Telemed, Synexa Life Sciences, Telix Pharmaceuticals.

Keeping you up to date on recent developments in cardiology, including: Mobile smartphone tech tied to better clinical outcomes for OHCA; Lung scans for earlier COVID-19 detection; Cholesterol meds affects the organs differently.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CSL, DBV, Chiesi, Imugene, Innocare, Innovation, Janssen, Neuraly, Pharmaxis, Polarityte, Poseida, Provention, Roche, Senhwa, Taigen.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamas, Addex, Amphilix, Astrazeneca, Augmenta, Biospecifics, Blue Water, Calithera, Checkpoint, China Grand Pharmaceutical, CNS Pharmaceuticals, Daewoong, Decibel, Endo, Eurofins, Fusion, Genequantum, Hillstream, Horizon, Indivior, Isofol, Janssen, JT Pharmaceuticals, Mylan, Mymetics, Novavax, Ocuphire, Pfizer, Prevail, Recombinetics, Regulus, Rexahn, Samsung Biologics, Sanofi, Santhera, SK Biopharmaceuticals, Telix, Tempus, TFF, Titan, Zucara.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aim, Aivita, Aligos, Arcutis, Astrazeneca, Curevac, Daiichi, Eli Lilly, Gritstone, Humanigen, Immunic, Incyte, Jounce, Mindmed, Novartis, Resverlogix, Revimmune, Rhythm, Shionogi, Sun, Symvivo, Tetra, Tiziana, UCB, Ultimovacs.

The latest global regulatory news, changes and updates affecting biopharma, including: Canada prepares for resurgence of COVID-19 shortages; Russia sets drug pricing structure.

The U.S. FDA is no longer reviewing lab-developed tests (LDTs) under the emergency use authorization (EUA) program, which eliminates product liability protection for them under the Public Readiness and Emergency Preparedness (PREP) Act. Harvard’s Michael Mina said on an Oct. 30 press briefing that the PREP Act question could be extended to LDTs administratively even outside EUA review, a move he said is under consideration based on his communications with Assistant Secretary for Health Brett Giroir.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts list of essential devices, drugs; Members of Congress query NIH’s Collins on RADx program; Imminent malware threat reported; CDC posts telehealth report; CMS unveils seven AI competition finalists.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic Canada, Perkinelmer.