Drugs

FDA Should Evaluate Foreign Offices’ Contributions: GAO

A Government Accountability Office (GAO) study says that FDA has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection, but has not assessed the contributions its foreign offices make to drug safety. “FDA has made progress in its strategic planning for its offices in China, Europe, India, and Latin America,” the report says, “but the lack of an assessment is inconsistent with federal standards for internal controls. Though FDA uses two performance measures to assess the foreign offices — number of medical product inspections and number of collaborative actions — the collaborative action measure does not capture the offices’ unique contributions to drug safety. Moreover, the foreign offices face persistently high vacancy rates.”

GAO says that FDA should assess the contributions of the foreign offices, and set a goal that distinguishes between the vacancy rates of staff in its foreign offices and those in its domestic international program office. It says the agency agreed with its recommendations.

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