Drugs

Contrast Agent, Radioactive Drug, OTC Drug Status Clarified

Attorneys James Bolani and Bonnie Odom (Epstein Becker Green) say a small section buried in the Consolidated Appropriations Act of 2023 clarified the regulatory status of contrast agents, radioactive drugs, and over-the-counter monograph drugs. “The new law brings to an end the uncertainty regarding the regulatory status of these product classes following the court case Genus Medical Technologies v. FDA and the subsequent Request for Information issued by FDA in 8/2021 that offered the notion of reclassifying products that had been regulated as drugs for several decades as medical devices,” the attorneys write in an online post.

They say that although FDA was not compelled to make such reclassifications as a result of Genus and could classify products as drugs, even if they lack chemical action, the clarification of the law brings a level of certainty to the regulatory status of the three classes of products that could provide substantial benefits to innovation. They also say FDA has an opportunity to build on the regulatory clarity through its user fee waiver policies that should help clear, and not hinder, the path for small pharmaceutical companies to pursue innovative drug development efforts.

The post outlines the products that are deemed drugs and not deemed drugs and looks ahead to possible future actions affecting product jurisdiction and incentivizing drug development.

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