Drugs

Yuki Gosei Kogyo Inspection Observations

FDA has released the FDA-483 issued following an 11/13-11/17/17 inspection at Yuki Gosei Kogyo, a Fukushima, Japan, active pharmaceutical ingredient (API) manufacturer. The document contains nine specific inspection observations:

laboratory control procedures are not followed;
records associated with drug substance production and within the retention period for such records were not made readily available for authorized inspection;
supervisory oversight over the laboratory electronic systems and data is deficient;
the quality unit lacks adequate control of expired laboratory reagents, samples to be tested, and finished batches;
the quality unit lacks adequate controls over GMP documents;
document control of laboratory testing records by the quality unit is inadequate;
equipment used in the manufacture or holding of drug components is not of appropriate design to facilitate operations for its intended use and maintenance;
each lot in shipment received was not identified with a distinctive code for each container or grouping of containers for components; and
equipment used during laboratory operations and production of an intermediate or API are not appropriately identified.

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