Drugs

Small Entity Compliance Guide on LDT Phase-out

FDA has posted a guidance entitled “Laboratory Developed Tests: Small Entity Compliance Guide.” The document discusses the agency’s phase-out approach for laboratory-developed tests (LDTs) so that in-vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs (i.e., FDA’s expectations for compliance will typically be the same).

The agency’s phaseout policy does not apply to certain tests that were excluded from its general enforcement discretion approach. FDA continues to generally expect that tests within the following categories will comply with applicable device requirements:

Tests that are intended as blood donor screening or human cells, tissues, and cellular and tissue-based products (HCT/P) donor screening tests required for infectious disease testing under 21 CFR 610.40 and 1271.80(c), respectively, or required for determination of blood group and Rh factors under 21 CFR 640.5;
Tests intended for emergencies, potential emergencies, or material threats declared under section 564(b) of the FD&C Act; and
Direct to consumer (DTC) tests, intended for consumer use without meaningful involvement by a licensed healthcare professional.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome