The issues facing the EU’s Medical Device Regulation and the In Vitro Diagnostic Regulation are the stuff of legend, but the EU’s notified body group, TEAM NB, has proposed a mechanism to deal with some of the administrative problems.
The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in that the warning letter stakes out the position that any reading of blood pressure is “inherently associated” with hypertension.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainnova Tech, Aquedeon Medical, Caro Health, Clarimed, Fortrea, Healthcare Outcomes Performance, Ocular Therapeutix, Nanopalm, Rakovina, Renata, We Are Human.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Enable Injections.
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.
The largest genome-wide association study to date of myalgic encephalomyelitis/chronic fatigue syndrome has identified eight genetic loci that are significantly associated with the chronic debilitating condition. Onset of ME/CFS often is traced back to an infection and four of the loci involve genes that are expressed in response to viral or bacterial infections.
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