FDA Policy/General

FDA Didn’t Submit OIG Clearance Documents: Report

The HHS Office of Inspector General (OIG) says FDA failed to submit an OIG clearance document for any of the 166 audit recommendations during FY 2016 and 2016. As a result, an OIG report says, all 166 were outstanding and listed on the stewardship report as past due for resolution as of 9/30/16.

However, the report continues, for 134 of the 166 recommendations FDA did address the audit recommendations in detail, to include statements of corrective actions, in its comments on the reports. OIG says the 166 past-due recommendations were procedural in nature and none involved dollar amounts such as recommended disallowances.

The agency recommends that FDA finalize and implement formal policies and procedures for the resolution of audit recommendations, promptly resolve the remaining 32 recommendations that were past due as of 9/30/16, and reconcile each month’s OIG audit resolution information with FDA’s audit resolution records and follow up on any differences noted.

The report says FDA concurred with the recommendations and described corrective actions it had taken or planned to take.

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