Drugs

FDA Releases Sekisui Medical FDA-483

FDA has just released the FDA-483 form listing 10 observations from its 6/13-6/17/16 inspection at Sekisui Medical Co., Iwate, Japan. Deviations from CGMP regulations for active pharmaceutical ingredients noted on the form were:

failing to maintain and review all raw data;
failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data;
failing to design and monitor the water system to ensure it is suitable for its intended use;
failing to ensure cleaning procedures are effective;
failing to maintain and clean equipment;
failing to demonstrate process validation is in a state of control;
failing to establish scientifically sound and appropriate test procedures;
failing to ensure the active pharmaceutical ingredients meet established specifications for quality and purity;
failing to establish impurity profiles; and
failing to establish a system to control the issuance of documents.

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