Drugs

Remote Regulatory Assessments Draft Guide

FDA is making available a revised draft guidance entitled “Conducting Remote Regulatory Assessments (RRA) — Questions and Answers.” The document clarifies the agency’s answers provided in a 2022 draft guidance regarding: (1) the benefits of an RRA, and any consequences for not participating; (2) how a facility will know an RRA is being requested, and whether it is mandatory or voluntary; (3) when and how FDA may initiate an RRA; (4) how FDA may conduct RRAs relative to inspections or activities by state and foreign regulatory partners; (5) what an establishment should expect during an RRA, including overall process and technological expectations, and how consent may be established for a voluntary RRA; (6) how FDA will seek to provide for ongoing communication between FDA and an establishment; and (7) what may occur upon the completion of an RRA.

The agency says its experiences with RRAs have identified significant benefits in using them. “For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers and in gaining compliance insight when it was not practicable to inspect,” the guidance says. “RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning.”

Additionally, the agency says it is issuing this guidance to promote greater consistency in the way RRAs are conducted, “including explaining processes for responding to an RRA request, and outlining factors we use for evaluating whether an establishment has responded timely and appropriately to a mandatory request.”

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