Drugs

FDA: Nippon Fine Chemical Limited, Refused Inspection

FDA says that Nippon Fine Chemical Co., Takasago City, Hyogo, Japan, limited and/or refused an FDA inspection when an investigator came to the company on 12/14/15. A 9/15 Warning Letter says that under the Federal Food, Drug, and Cosmetic Act, drugs produced by the company are adulterated because they are manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.

The letter says the company barred the investigator’s access to the quality control laboratory, refused to provide copies of documents, and limited photography. The firm was placed on Import Alert on 8/8.

Until FDA is able to inspect the facility and confirm compliance with current good manufacturing practice, the letter says, it may recommend withholding approval of any new applications or supplements listing the company as a drug manufacturer. And shipments of articles manufactured at Nippon Fine Chemical are subject to refusal of admission into the U.S.

The company was told to respond within 15 days.

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

Read more

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