Drugs

Rep. Waltz Questions FDA’s Telework Policy

Congressman Mike Waltz (R-FL) has written FDA Commissioner Robert Califf asking for clarification on the agency’s “telework policies… which have minimized the operational standards for approving critical drugs and therapeutics.”

Waltz noted in his 2/1 letter that it has been four years since the beginning of the pandemic and FDA has “still not fully reopened to serve the American public. This has especially harmed much-needed services from the FDA as the agency continues to restrict required in-person meetings needed to approve medical therapies for the American public. It’s past time to reopen!”

The letter also is critical of FDA’s decision to maintain a “hybrid work environment” that restricts the number of participants allowed to speak during the meetings as well as the number of participants allowed to attend in-person. Additionally, it notes that FDA’s White Oak campus has a “limited number of conference rooms available to hold these meetings as they work to upgrade the existing rooms with the technology and equipment necessary to support the hybrid meeting format.”

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