Drugs

FDA Lifts Staar Surgical Warning Letter

FDA has issued Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the agency’s satisfaction. The company says that the action is the “result of a comprehensive remediation program that not only addressed the issues raised by the FDA in the 2014 Warning Letter, but included the assessment, remediation and upgrade of all aspects of Staar’s quality systems to assure compliance with Quality System Regulations (QSR)... We have steadfastly initiated and promoted a culture of quality which emphasizes prevention and accountability throughout the organization.”

The 2014 Warning Letter cited the firm for Quality System Regulation violations associated with its Visian Myopic ICL Phakic Intraocular Lens, Affinity Collamer lens insertions accessories, and a collamer glaucoma drainage device. According to the letter, Staar failed to establish adequate procedures for design controls for the devices. It also cited the firm’s failure to establish and maintain a design history file or a procedure for design transfer for each type of device to “demonstrate that the design was developed in accordance with the approved design plan.” Until corrections were made, FDA said any pending PMAs that could be impacted by the violations would not be approved.

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