FDA Stakeholder Update - February 13, 2020

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 Announcement FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User The FDA authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient’s heart that are of acceptable diagnostic quality. [02/07/2020] FDA Voices FDA Arming Itself with Science to Help Prevent Cyclospora Infections Cyclospora cayetanensis is so small that it can only be seen with a microscope. However, there is nothing small about the FDA's work to help protect consumers from the foodborne illness that this parasite can cause. Cyclosporiasis is an intestinal illness caused by consumption of foods, mainly fresh produce, that are contaminated with Cyclospora. The FDA has been working to help prevent contaminated product from reaching consumers, gathering the scientific knowledge that will help to better detect the parasite in food and the environment, and gathering data to better understand how food is contaminated by the parasite and help prevent contamination in the future. We’re also sharing what we know with stakeholders in the public and private sectors. [2/11/2020]

Guidance Document Bridging for Drug-Device and Biologic-Device Combination Products - Submit Comments by 02/18/2020  This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products. Requesting FDA Feedback on Combination Products - Submit Comments by 02/24/2020 The purpose of this guidance is to discuss ways in which combination product sponsors  can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.  These interactions can occur through application-based mechanisms (generally the most efficient and effective approach), such as the pre-submission process used in CDRH and CBER  and the formal meetings used in CDER and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.  Consumer Updates What to Know and Do About Possible Nitrosamines in Your Medication The FDA is investigating several potentially cancer-causing substances, called nitrosamines, recently found in some drugs, including those used to treat elevated blood pressure, heartburn, and acid reflux. Some of these drugs from certain manufacturers – including angiotensin II receptor blockers (ARBs), ranitidine, and nizatidine – have been recalled because of nitrosamine impurities. The FDA knows this is a concern. Patient safety is the FDA’s top priority. We continue to work with manufacturers to investigate the source of nitrosamines in drugs and whether they are at a high enough level to pose risks to human health. The FDA and manufacturers are testing samples of certain medications that may contain nitrosamines and will continue to take quick and appropriate action when needed to protect American consumers.

Recall and Safety Information MiniMed 600 Series Insulin Pumps by Medtronic : Class I Recall - Due to Incorrect Insulin Dosing   Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. [2/12/2020] Public Meetings and Workshops FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development Date: February 24, 2020 Time: 9:00 AM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The FDA Rare Disease Day 2020 meeting will include perspectives from various stakeholders in rare disease product development. The specific goal of this meeting is to identify challenges and solutions in rare disease product development to optimize rare disease medical product development.  Register: If you wish to attend in-person or via webcast, please register at Eventbrite.   FDA/FTC Workshop on a Competitive Marketplace for Biosimilars Date: March 9, 2020 Time: 9:00 AM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The purpose of the public workshop is to discuss FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace.  Register: If you wish to attend in-person or via webcast, please register at Eventbrite. Patient-Focused Drug Development for Vitiligo Date: March 30, 2020 Time: 1:00 PM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: FDA is interested in hearing patients’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. Register: If you wish to attend in-person or via webcast, please register at Eventbrite. For a more comprehensive list of public meetings involving the FDA, please visit here.