FDA Policy/General

GAO Calls Out Unfinished FDA Inspection Recommendations

The U.S. Government Accountability Office (GAO) has written HHS about the need for FDA to make it a high priority to act on inspection-related recommendations that are still open from previous GAO reports.

One recommendation from a 1/28/2021 report (GAO-21-265) called for FDA inspection plans for future fiscal years to be developed to ensure that they identify, analyze, and respond to the issues presented by the Covid-related backlog of inspections that could jeopardize the goal of risk-driven inspections. “To fully implement this recommendation, FDA needs to provide documentation that its inspection plans account for, and respond to, the backlog of drug manufacturing inspections,” GAO says. “Until it does so, FDA’s backlog of inspections may jeopardize its strategic goal of shifting toward exclusively risk-driven inspections.”

Another recommendation from a 12/2016 GAO report (GAO-17-143) wanted FDA to assess the effectiveness of its foreign offices’ contributions to drug safety by systematically tracking information to measure whether the offices’ activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and Warning Letters. In February, FDA told GAO that it drafted and was reviewing indicators of progress and desired outcomes. GAO’s letter said the agency needs to finalize and systematically track the “indicators of progress and desired drug safety-related outcomes to assess the effectiveness of the foreign offices’ contributions to drug safety.”

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