FDA Policy/General

FDA Delays Foreign Inspections Through April

FDA said 3/10 it is postponing most foreign inspections through April due to the Covid-19 outbreak. An Alston & Bird FDA Compliance and Enforcement Advisory says that inspections outside the U.S. deemed to be “mission-critical” will be considered on a case-by-case basis. The advisory says the agency notice referenced additional tools available as part of its multi-pronged and risk-based approach to enhance the safety of imported products including (1) denying entry of unsafe products into the U.S.; (2) physical examinations and/or product sampling at the U.S. border; (3) reviewing a firm’s previous compliance history; (4) using information sharing from foreign governments as part of mutual recognition and confidentiality agreements; and (5) requesting records in advance of or in lieu of on-site drug inspections.

The advisory lists these key areas for FDA-regulated industries to consider: mission-critical inspections, a potential increase in domestic inspections, record requests in advance of or in lieu of drug establishment inspections, waiving current good manufacturing practices under an emergency use authorization, foreign inspections of medical device manufacturers, focus on in vitro diagnostics, and increased scrutiny over Foreign Supplier Verification Rule implementation for domestic food manufacturers.

“Regulated industry should continue to monitor FDA’s approach to foreign inspection and oversight of regulated products imported into the U.S. and be able to respond accordingly,” the advisory concludes.

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