Drugs

Name Placement in Drug Ads Final Guidance

FDA has posted a final guidance on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The document clarifies the agency’s requirements and addresses circumstances under which FDA intends to not take enforcement action in such matters.

The guidance recommends that the established name be placed directly to the right of or directly below the proprietary name. It also recommends that the proprietary name and the established name not be separated by placement of “intervening matter that would in any way detract from, obfuscate, or de-emphasize the established name of the product or obscure the relationship between the proprietary name and the established name.” Intervening matter includes a logo, tagline, or other graphics, it says.

Additionally, the guidance provides hypothetical examples of established name presentations that do not have commensurate prominence with proprietary names. For electronic and computer-based promotion that contains “running text,” the agency says it does not intend to object to fewer appearances of the established name, provided that the established name accompanies the proprietary name at least once per Web page where the proprietary name most prominently appears on page. “However, if the proprietary name is not featured but is part of the running text, the established name is required to accompany the proprietary name at least once in the running text,” it says.

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

Read more

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