Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

The U.S. Department of Health and Human Services (HHS) today released a draft report that includes a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT) that promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally-mandated report proposes to clarify federal regulatory oversight of health IT products based on a product’s function and the potential risk to patients who use it.

For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine chest.