FDA Stakeholder Update - September 26, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcements Statement on final guidance to help advance development of novel treatments for ALS Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago. We recognize that scientific progress across different disease and therapeutic areas has been uneven, particularly lagging for complex neurological diseases, such as amyotrophic lateral sclerosis (ALS). In part, this is because the underlying causes of severe neurological diseases are often not well understood, contributing to the challenge in the development of drug and biological treatments. [9/23/2019] Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis. As we observe Prescription Opioid and Heroin Epidemic Awareness Week, a time when we acknowledge the devastating toll the opioid crisis has inflicted on our country, we felt it was essential to clarify important information about naloxone, an emergency opioid overdose reversal treatment. Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths. [9/20/2019]

FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products   The FDA issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products. [09/20/2019] FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program As a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes   Orthopedic Non-Spinal Metallic Bone Screws and Washers Spinal Plating Systems The FDA also updated the Safety and Performance Based Pathway final guidance.  [09/19/2019]

Safety Information/CTP Lung Illnesses Associated with Use of Vaping Products Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory illness associated with use of vaping products. The FDA and CDC are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges. [9/26/2019] Prevention Through Public Education Preliminary data from the National Youth Tobacco Survey show that in 2019 more than a quarter of high school students had used e-cigarettes in the last 30 days. And each day in the United States, about 2,000 youth under 18 years of age smoke their first cigarette. Exposure to nicotine as a teen can cause short-term and long-term effects on the brain that promote addiction to nicotine. To protect the next generation from tobacco-related disease and premature death, FDA has created a series of groundbreaking public education initiatives to prevent young people from ever starting to use tobacco and to help addicted smokers quit. [9/24/2019]