FDA Policy/General

FDA Postpones Foreign Inspections Until May

FDA has postponed foreign inspection of regulated products until May due to the coronavirus outbreak. “Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis,” FDA commissioner Stephen Hahn says in a release. The State Department has also issued travel restrictions and access restrictions imposed by host countries have contributed to the inspection postponement, the agency says.

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” Hahn says. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”

In lieu of inspections, FDA says it is currently conducting physical examinations and product sampling at U.S. borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting manufacturing records. “The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law,” the agency says.

Meanwhile, CDER director Janet Woodcock says that in addition to inspections being postponed, Center-organized external meetings, conferences, and workshops will be postponed or canceled from 3/10 through April. Woodcock urged staff to hold meetings with external stakeholders through teleconference, when possible.

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