Drugs

Cures Act Clarifies Combination Product Designation: Attorneys

Hogan Lovells attorneys say that one of the features of the 21^st Century Cures Act is an attempt to bring consistency and efficiency to the regulation of combination products. In an online blog post, the firm says that the new law brings two important clarifications to the process of determining a combination product’s primary mode of action (PMOA).

While the Cures Act codifies the current agency practice of requesting a determination from the Office of Combination Products whenever jurisdiction is unclear, as well as maintaining the requirement for FDA to review a combination product under a single application whenever appropriate, the attorneys write, it also clarifies the way in which FDA is to consider PMOA. The new provision prohibits the agency from “solely” basing the determination on chemical action without setting any other rules or standards for PMOA determination, the blog says. Even so, the act requires FDA to determine PMOA as “the single mode of action … expected to make the greatest contribution to the overall intended therapeutic effects.”

The act also provides for combination product meetings with FDA upon request after the agency makes a PMOA determination, during which the sponsor and agency can discuss and agree upon issues and requirements that should be addressed by the sponsor for product approval. And it creates a clear process for sponsors to challenge FDA’s initial PMOA determination and agency Center assignment under a mini-burden-shifting framework. The attorneys write that they are not sure what problem this provision seeks to solve since most sponsors can interact quite closely with the agency’s Office of Combination Products under the existing system.

The blog analysis also covers combination products with an approved constituent part, device applications involving approved constituent drugs, combination product guidance, and allowing specific deviations from current good manufacturing practice.

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