FDA Policy/General

FDA Campus Remains High-risk Security Facility

While FDA’s consolidated campus in White Oak, MD has offered more collaboration opportunities and efficiencies such as shared laboratories, the campus and its use has grown rapidly and remains a high-risk security concern, according to a new Government Accountability Office report. “(D)ue to concerns about managing traffic and parking, FDA has faced challenges implementing the required vehicle separation system and controlling visitor access to parking, which was identified in the 2014 risk assessment,” the report says. “In the absence of these recommended security features, FDA is not in compliance with guidance and may put the campus at risk. According to FDA officials, FDA plans to institute a vehicle separation system, controlling visitor access to parking, in the near future. However, to-date, FDA has not documented plans for its vehicle separation system.”

The campus is still partially complete, with nine of the 10 planned office buildings constructed and 27% more staff than the 8,300 staff planned for in the completed buildings, the report notes. “FDA has taken steps to plan for the future of the White Oak campus, but its planning efforts lack some elements of leading practices for facilities planning,” it says.

GAO recommends that FDA (1) implement a vehicle separation system as called for in a 2014 risk assessment; (2) establish linkage between its strategic priorities and its facilities plans; and (3) develop a strategy for collecting and analyzing needed data to inform proposed facilities planning efforts.

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