Drugs

CDER Naloxone Model Drug Facts Label

In a move to increase access to naloxone, perhaps even through regulatory approval of over-the-counter sales, CDER staff developed a model drug facts label for such sales to determine whether consumers understood the key statements for safe and effective use. Writing in a New England Journal of Medicine special article, the staff reports that consumers sufficiently understood six of the eight instruction components in the label and came close on the other two. “Overall, FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales,” the article says.

The agency says its decision to develop a model drug facts label and to conduct a study to assess consumer comprehension represents a considerable departure from the typical drug development process in which the sponsor conducts all testing and comes to FDA for approval.

“This label performed well in facilitating understanding of the important steps needed in evaluating a person who appears to have overdosed and in administering naloxone,” the article concludes. “The success of this label-comprehension study has enabled much of the work needed to secure the over-the-counter availability of naloxone and will be key to leveraging over-the-counter product development as a possible means to increasing access to a life-saving drug. We encourage industry sponsors to use this model label to accelerate development initiatives that will ultimately allow for wider access to naloxone.”

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