Biologics

Steiner Biotechnology ‘Objectionable Conditions’ Cited

An FDA Office of Bioresearch Monitoring Operations 6/24-6/28/19 inspection at Steiner Biotechnology, Henderson, NV, found “objectionable conditions” related to the firm’s participation in nonclinical Good Laboratory Practice studies concerning the Skeletal Graft and Ridge Graft. A just-released 2/3 Warning Letter says specific deviations noted on an FDA-483 were:

failing to conduct nonclinical laboratory studies following the protocols;
failure of the quality assurance unit to inspect each nonclinical laboratory study at intervals adequate to assure the study’s integrity and to maintain written and properly signed records of each inspection, and failing to document in writing the responsibilities and procedures of the quality assurance unit with the method for indexing such records;
failing to ensure that specimens are properly identified by test system, study, nature, and date of collection; and
failing to ensure that the testing facility maintains a current summary of training and experience for each individual engaged in or supervising the conduct of a nonclinical laboratory study.

FDA says the firm’s responses to the inspection observations were not adequate. Steiner was told to provide documentation of the additional corrective and preventive actions that it had taken or will take to correct the violations and prevent their recurrence in current or future studies for which it is the testing facility, with a timetable for completing the actions.

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