Drugs

Proprietary Name Guidances

FDA has issued two guidances on developing proprietary names for human drug products. One guidance covers prescription drug products and the other covers non-prescription products. The documents say they describe best practices to help minimize proprietary name-related medication errors and otherwise avoid the adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act and its regulations.

They also describe the framework the agency uses to evaluate proposed proprietary names that is available for sponsors to use before a product bearing the proprietary name is marketed. The guidances do not address the designation of established names or proper names.

FDA says that using the best practice recommendations and other assessment tools addressed in the guidance is not mandatory and their application does not dictate specific outcomes. “Assessments of a proprietary name are necessarily fact-specific and, therefore, FDA’s determinations are made on a case-by-case basis, considering the totality of the information,” the agency 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