FDA Stakeholder Engagement Update - January 30, 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 launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data FDA announced the launch of an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data. Quick Reference Guide for PEPFAR Database PEPFAR Database Frequently Asked Questions [01/29/2020] FDA Continues Strong Support of Innovation in Development of Gene Therapy Products This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. To date, the FDA has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices. In that spirit, the FDA is announcing the release of a number of important policies: six final guidances on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations. [1/28/2020] FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks. As part of FDA’s ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests. [1/27/2020]

Draft Guidance Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.  The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.   You may submit comments here. [1/30/2020]

Public Meetings and Workshops The Oncology Center of Excellence (OCE), Envisioning Oncology Product Development for 2025  Date: February 5, 2020 Time: 8:30 AM - 1:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center A, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: As the OCE celebrates its third year of operation, we invite the public to hear about some of our innovative pilot projects and programs and solicit feedback from the oncology community. Register: If you wish to attend in person or via live webcast, please register here by Tuesday, February 1, 2020, 5:00 PM ET 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 live webcast, please register at Eventbrite. FDA's Communications About the Safety of Medical Devices Date: April 1, 2020 Time: 8:30 AM - 4:30 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 goal of this public meeting is to share the FDA’s current practices about medical device safety communications, and to hear from our stakeholders (including patients and caregivers, healthcare providers, regulated industry, and media) about how we can improve our safety communications to assure they receive the information they need in a timely, clear, and consistent manner.  For a more comprehensive list of public meetings involving the FDA, please visit here.