Drugs

FDA Warning, Import Alert on Contaminated Eyedrops

FDA has issued an import alert and a safety warning on EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. The over-the-counter products are manufactured by Global Pharma Healthcare Private Limited in Tamilnadu, India. “Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the agency alert says.

FDA says it placed the company on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert is intended to stop the products from entering the U.S.

FDA says Global Pharma has issued a recall after the agency recommended it due to the company’s current good manufacturing practice (CGMP) violations, “including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.”

The agency is working with the CDC and state and local health departments to investigate the multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. So far, CDC has identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence the products, the agency says.

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