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.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuhealth, Applied DNA Sciences, Bendit Technologies, Biocartis Group, Bone Therapeutics, Catalent Pharma Solutions, Closedloop.ai, DNAfit Life Sciences, Exact Sciences, Fitbit, Genomic Health, Health Catalyst, Livongo Health, Mammoth Biosciences, Mayo Clinic, Myapps, Natera, Optomec, Oxsed, Prenetics, Ping An, Premier Medical Laboratory Services, Progressive Care, Sanara Medical, Teladoc, Telli Health, Vocalis, Zerigo.

Keeping you up to date on recent developments in neurology, including: Software developed to objectively calculate white matter hyperintensities; CSF biomarkers point to underlying cause of neural damage in COVID-19; Scientists discover how cryptochrome mutation leads to sleep disorder; Physical labor significantly increases the risk of dementia.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Avrobio, Biocryst, Biogen, Cerecin, Equillium, Nexus, Novartis, Novo Nordisk, Regeneron, União Química, Trevena.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC Therapeutics, Genmab, Genprex, Havn, Innovation Pharmaceuticals, Janssen, Novartis, Oscine, OSE Immunotherapeutics, Protagonist, Sana.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Axovant, Bellicum, Biolinerx, Cerevel, Lilly.

TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.