Drugs

Testing Deficiencies Cited at Asahi Kasei Finechem API Plant

FDA has cited Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Japan. According to an FDA inspection report, the facility failed to ensure that analytical testing methods used for finished product release met required standards of accuracy and reliability. Investigators determined that the company had not performed validation studies on certain in-house analytical methods, nor had it adequately verified United States Pharmacopeia (USP) methods used to test drug products manufactured for the U.S. market.

The agency cited several examples of unvalidated in-house methods, including tests for heavy metals, E. coli, and Salmonella species used in finished product release testing. In addition, FDA identified multiple USP methods — such as loss on drying and infrared identification tests — that were used without proper method verification.

“These failures compromise the firm’s ability to demonstrate that test results accurately reflect product quality and compliance with specifications,” the FDA Form 483 said.

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