Devices

Legislators Continuing to Push for VALID Act

Speaking during a 2/22 online presentation sponsored by Friends of Cancer Research, Reps. Donna DeGette (D-CO) and Larry Buschon (R-IN) stressed their determination to see approval of the VALID Act (Verifying Accurate Leading Edge IVCT [in vitro clinical test] Development Act of 2021 during the current Congress. The meeting topic was “Supporting Development of Diagnostic Tests for Unmet Needs.”

DeGette said the bipartisan bill would provide a legislative framework for FDA to regulate diagnostic tests. She also said they are looking for a pathway for expedited review of some tests.

Buschon said that in his previous experience as a doctor before coming to Congress he found that some tests don’t have the clinical and analytical accuracy needed to be used in making good medical decisions. He said he sees this as a pivotal year for the approval of VALID.

As part of a subsequent panel discussion, CDRH biologist Soma Ghosh discussed actions FDA has taken to address the challenges in diagnostic tests and said the agency is updating its policies whenever possible. She stressed the need for stakeholders to continue to talk with each other and the agency about the issues.

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

Read more

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