Drugs

New CDER Web Page Housing EUA Docs/Requirements

CDER has created a new Web page to house scientific review documents supporting emergency use authorizations (EUAs) for drug and biological therapeutic products, including any amendments. The Center says that the page is intended to “promote public confidence in FDA’s scientific review process” and it is “consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals.” The most recent postings include:

A requirement for Eli Lilly on the monitoring and assessment of emerging global viral variants involving its EUA for bamlanivimab.
A similar requirement on Lilly’s EUA for bamlanivimab and etesevimab.
A similar requirement on Regeneron Pharmaceuticals’ EUA for casirivimab (REGN10933) and imdevimab.

Each requirement contains language requiring the manufacturer to “establish a process for monitoring genomic database(s) for the emergence of global viral variants of SARS-CoV-2.” It also asks for a summary of the process to be submitted to the agency as soon as practicable. And, it requires each manufacturer to “provide reports to the agency on a monthly basis summarizing any findings as a result of its monitoring activities and, as needed, any follow-up assessments planned or conducted.”

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