Drugs

Juno Therapeutics Inspection Report Released

FDA has just released the establishment inspection report issued following a 10/7-10/16/20 agency inspection at Juno Therapeutics, Bothell, WA. The report says no previous inspections had been conducted.

The six inspection observations in the FDA-483 portion of the report were:

failing to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
failing to always include the appropriate conclusion and follow-up in written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications;
failing to include in a written procedure for manufacturing material visual inspection specification of when in the manufacturing process certain materials and containers are inspected for leaks;
failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing to have laboratory controls include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to justify deviations from written test procedures to assure compliance with established specifications and standards.

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