FDA Policy/General

FDA Bioresearch Inspection Findings Out

FDA has released the FY 2022 annual inspection metrics for the compliance programs within the agency’s Bioresearch Monitoring (BIMO) program. BIMO inspections (domestic and foreign) were conducted by the Office of Regulatory Affairs, except for a portion conducted by CDER subject matter experts.

According to the metrics, the most common clinical investigator inspectional observations involved compliance with Form FDA 1572 -Statement of Investigator, failure to comply with requirements (protocol compliance), and failure to follow the investigational plan (protocol deviations). Additionally, the following observations were also some of the top cited:

Inadequate and/or inaccurate case history records; inadequate study records
Inadequate accountability and/or control of the investigational product
Safety reporting; failure to report and/or record adverse events
Inadequate subject protection; informed consent issues

Remote regulatory assessments, which replaced in-person FDA inspections during the Covid-19 pandemic, appear to be tapering off for BIMO inspection as investigators resume traditional domestic and foreign site audits. In FY 2021, FDA conducted 140 BIMO-related remote regulatory assessments, but in 2022 that number dropped by 36% to 89 assessments.

Last year, FDA released a draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” on how such assessments may be used post-Covid restrictions. “We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health,” the agency said at the time. “For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that a RRA is an appropriate tool. RRAs may also be used to efficiently assess establishments identified in product applications when these establishments have a prior history of compliance.”

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