Drugs

CDER Updates Inactive Ingredient Database

FDA has updated its inactive ingredient database (IID) that allows users to perform electronic queries to obtain accurate maximum daily exposure (MDE) information for excipients for each route of administration. “MDE is the total amount of the excipient that would be taken or used daily based on the maximum daily dose of the drug product in which it is used,” an FDA notice says. “As FDA obtains more MDE information, we will populate more excipient MDEs in future IID publications. FDA expects many MDE levels to increase as the agency gathers additional information on excipient exposure levels.”

FDA says that the enhancements are intended to help industry make informed decisions about excipient selection during drug development. “For example, excipient MDE information may help in decisions about whether additional excipient qualification is warranted when an applicant proposes excipients in a regulatory submission.” Additionally, the agency provides a “change log” to inform users of recent IID updates and corrections.

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