Drugs

Mandatory Biologics Monograph Could Hurt Innovation: FDA

CDER Office of Biotechnology Products director Steven Kozlowski says FDA supports United States Pharmacopeia monograph standards for small molecule drugs, but believes that a mandatory monograph for biologics “would impede innovative technologies, as well as place unnecessary burdens on industry and on FDA reviewers.” Writing in an online CDER Conversation, Kozlowski says that if a company conceives of a novel or more efficient manufacturing process for a biological product that will make the drug more accessible, that new process may trigger some variability in the product.

If there is a monograph for that particular biological product in place that does not accommodate this change in manufacturing, he writes, the new product could not be approved. “When it comes to transformational manufacturing for these products that could lead to better access,” Kozlowski says, “the rigidity of the monograph model may hamper progress. In contrast, the agency’s standards provide more flexibility to take into account product characteristics, without sacrificing safety or efficacy.”

The post also stresses that biologic products for which there is no USP monograph are not more likely to have quality problems or be unsafe because of the FDA approval process.

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