Devices

American Preclinical Good Lab Practice Violations

A 3/19-4/13/18 FFDA inspection at American Preclinical Services, Minneapolis, MN, found violations of Good Laboratory Practice regulations in the company’s participation in several nonclinical laboratory studies. A 2/12 Warning Letter corrects a Warning Letter issued 10/4/18. Inspection observations listed on an FDA-483 were:

failure of the study director to fulfill responsibilities;
failure of the quality assurance unit to fulfill responsibilities;
failing to ensure that all information needed to specifically identify each animal within an animal housing unit appears on the outside of that unit and failing to ensure that water used for the animals was analyzed; and
failing to ensure required labeling of reagents, storage contains for test and control articles, specimens.

FDA said the firm’s responses to the observations were inadequate. American Preclinical was told to provide documentation of corrective actions it has taken or will take to correct the violations and to prevent the recurrence of these or similar violations in current for future studies for which it is the testing facility, with projected completion dates for all actions. The company also was told to provide a complete list of all nonclinical laboratory studies of FDA-regulated medical devices for the last five years.

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