Drugs

FDA Develops 2 OTC Naloxone Drug Facts Models

In an effort to encourage drug companies to enter the over-the-counter market and increase access to the opioid overdose reversing drug naloxone, FDA has developed a model drug facts label (DFL) with easy-to-use pictograms on how to use the drug. A statement from FDA commissioner Scott Gottlieb says the agency also conducted label comprehension testing to ensure the instructions were simple to follow.

FDA has now posted model DFLs for use with a nasal spray or an auto-injector and the supporting FDA review (links included in the statement). “These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” Gottlieb says. “The model DFL contains the information (except for individual product-specific information) that a consumer needs to administer naloxone safely and effectively.”

The commissioner says this is the first time the agency has proactively developed and tested a DFL for a drug to support development of an OTC product.

According to Gottlieb, the product-specific instructions in each of the models are placeholders that have not been tested by FDA for comprehension or human factors performance. “Sponsors can replace these placeholders with their own product-specific information and test it if necessary,” he writes. “I personally urge companies to take notice of this pathway that FDA has opened for them and come to the agency with applications as soon as possible.”

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