FDA Glucose Meter Draft Guidelines Attract More Criticism From Congress
This article was originally published in The Gray Sheet
FDA draft guidance documents on glucose meters issued in January propose new accuracy standards that stray from updated international norms and would inappropriately restrict the use of OTC meters in health care facilities when needed, 85 lawmakers from the congressional Diabetes Caucus argue in a letter to Commissioner Hamburg.
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The US agency finalized two closely watched guidance documents for blood glucose systems used in the hospital and at home. The guidance focusing on hospital point-of-care systems included a key revision of proposed accuracy standards from a 2014 draft guidance that had been broadly maligned as too tough.
An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed. The agency says it is taking appropriate measures to address a safety issue, and that some of the criticism is misdirected.
Pharma manufacturing is operating well below normal levels in India, disrupted by labor absenteeism and supply chain issues amid the ongoing lock-down in the country, though the government is actively engaged in addressing bottlenecks. A speedy recovery is vital not just for domestic supplies.