Drugs

AveXis Inspection Observations

FDA has released the FDA-483 issued following a 7/24-8/2 inspection at AveXis, San Diego, CA, the control testing laboratory at the center of data manipulation concerns (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. An agency statement says FDA was informed 6/28 about the data manipulation issue that affects the accuracy of certain data from product testing performed in animals submitted in the BLA reviewed by FDA.

The document contains five inspection observations:

failing to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed;
laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
failing to fully follow the responsibilities and procedures applicable to the quality control unit;
laboratory records do not include complete records of any testing and standardization of laboratory reference standards; and
failing to follow established test procedures.

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