FDA Policy/General

Group Wants FDA to Regulate Only Through Regulations

The New Civil Liberties Alliance (NCLA) says FDA should “cease its ad hoc promulgation of guidance by which it seeks to bind private parties with the force of law…. All externally binding rules must implement statutory instructions and be adopted through notice-and-comment rulemaking.” The group’s petition includes a draft rule that it wants FDA to adopt, saying that through it the agency can “bring its rulemaking practices in to conformity with the Constitution, as well as help its rules withstand court challenges and endure beyond the preferences of the current administration.”

NCLA says its draft rulemaking would prohibit any FDA component from issuing, relying on, or defending improper agency guidance. “This rule would formalize and make more permanent policies and best practices from other agencies concerning any agency guidance that improperly attempts to create rights or obligations binding on persons or entities outside the FDA. As hereby proposed, it also would provide affected parties with a means of redress for improper agency actions.”

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