Devices

Tiger Selling Restricted Alere Test Kit: FDA

The CBER Office of Compliance and Biologics Quality says a Tiger Medical Web site is selling and distributing the Alere Determine HIV-1/2 Ag/Ab combo test kit without imposing the restrictions that are part of the kit’s approval. A 5/29 untitled letter says the agency’s approval of the test kit restricted the sale and distribution to prescription use by a practitioner such as a doctor for use in professional practice or for use by clinical laboratories that have an adequate quality assurance program to provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional material.

The letter says that although Tiger’s Web site includes a note that the product can only be purchased by a medical facility or a licensed physician, the company is not limiting sales to such customers and is not requiring a prescription or doctor’s order.

The letter asks that the company stop the sale and distribution of the test kits until such sale and distribution are restricted in accordance with the device’s approval.

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