FDA Stakeholder Update - October 11, 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 FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens The FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. [10/10/2019] FDA awards two grants for natural history studies in rare diseases The FDA announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over $4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments. Natural history studies closely look at how specific diseases progress over time. The natural history of a disease is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of treatment. [10/08/2019] FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases The FDA announced that it has awarded 12 new clinical trial research grants totaling more than $15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country. The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congress to encourage clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases. The grants are intended to substantially contribute to marketing approval of products to treat rare diseases or provide essential data needed for development of such products. [10/08/2019]

Updates related to Vaping Products Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses from Acting Commissioner of FDA, Ned Sharpless, M.D. Over the past several weeks, the FDA has been working tirelessly along with the U.S. Centers for Disease Control and Prevention (CDC) and other federal, state and local partners to investigate the distressing incidents of severe lung injuries and deaths associated with the use of vaping products. The latest number of reported cases and deaths, released by the CDC, continues to underscore the need for us to gather critical information and provide consumers with actionable information to help best protect themselves and their loved ones..

This is why, we’re strengthening our message to the public in an updated consumer alert stating that they should not use vaping products containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. Additionally, consumers who choose to use any vaping products should not modify or add any substances such as THC or other oils to products purchased in stores and should not purchase any vaping products, including those containing THC, off the street or from other illicit channels. [10/04/2019] FDA in Brief

Visit to JFK/Secaucus International Mail Facilities Acting Commissioner of FDA, Ned Sharpless, M.D., visited two international mail facilities (IMFs) to see the critical work being carried out by agency investigators in the FDA’s effort to combat overseas shipments containing illicit and potentially dangerous drugs and other products from reaching Americans: the IMFs at JFK Airport in Jamaica, New York and Secaucus, New Jersey. The nine IMFs across the U.S. receive mail from more than 180 countries, and it is part of the FDA’s mission to inspect, detect and intercept illegal products, including those that are

unapproved, counterfeit and/or potentially dangerous, such as illicit opioid products, counterfeit prescription drugs, medical devices, over-the-counter products, and products labeled as dietary supplements that may contain harmful ingredients. [10/09/2019]

Safety Information Check Your AED: Is it FDA Approved? The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories. Manufacturers of all necessary AED accessories, such as batteries, pad electrodes, adapters and hardware keys for pediatric use, must file a premarket approval application (PMA) by February 3, 2020. If a PMA is not filed by February 3, 2020, the manufacturer must cease marketing their accessories by February 3, 2021.

There are now FDA-approved AEDs available, and we encourage you to ensure your AED is FDA-approved; if it is not, we encourage you to begin making plans to transition to an FDA-approved AED. Check to see if your AED is FDA-Approved. Contact the manufacturer of your AED if you are not sure if your AED is FDA-approved. [9/26/2019] FDA Funding Available for Research Aimed at Reducing Preventable Harm from Medication FDA announced the availability of funding opportunities for Safe Use Research Projects under the FDA’s Safe Use Initiative. This initiative is committed to reducing preventable harm from drugs by soliciting and funding projects that seek to further research in the area of safe medication use. Research proposals to reduce preventable harm from drugs will be accepted between October 1, 2019 and March 27, 2020 for FY2020 funding. [10/04/2019] Public Meetings and Workshops

Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Final Guidance Date: October 16, 2019 Time: 12:00 PM - 01:30 PM EDT NOTE: You must dial-in to hear the presentation and ask questions Registration is not required

Public Meeting: Deemed Tobacco Product Applications Agenda: This meeting is intended to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles. Date: October 28-29, 2019 Time: 08:30 AM - 04:30 PM EDT Location: White Oak Campus - The Great Room, Conference Center