The Senate Health, Education, Labor and Pensions (HELP) Committee has posted its version of U.S. FDA user fee legislation, a bill that echoes many of the primary features of the version already at play in the House of Representatives. One critical difference is that the Senate bill includes legislation that would enable the FDA to regulate lab-developed tests (LDTs), the so-called Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the omission of which from the House bill ruffled a few feathers. The American Clinical Laboratory Association (ACLA) responded to the Senate bill with a May 17 statement applauding the inclusion of the VALID Act in the Senate user fee bill.
The European Commission (EC) has proposed new legislation directed toward formation of a European Health Data Space (EHDS), which is nominally intended to address some perceived gaps in the General Data Protection Regulation (GDPR). While this legislative proposal seems to interact with both the GDPR and pending EU legislation on artificial intelligence, the EHDS takes on the massive challenge of compulsory interoperability of electronic health records (EHRs). The EC unveiled the proposal with an emphasis on health data accessibility, although both the European Council and the European Parliament will now have their say over how the legislation will ultimately read.
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atamyo, Eli Lilly, Faron, Galera, Gedeon, Inmagene, Junshi, Mitsubishi, Point, Scpharmaceuticals, Sifi, Travere, Valneva, Zenas.
Regulatory harmonization is seen as vital to the development of markets for artificial intelligence (AI) and machine learning (ML), but there is some variation in the terminology used to describe these algorithms. The International Medical Device Regulators Forum (IMDRF) has posted a document that includes some definitions for ML terms such as unsupervised machine learning, a key development if regulations across the globe are to avoid a hopeless state of balkanization.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.