FDA Stakeholder Update – May 7, 2021

May 7, 2021 Dear Colleague, As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies. As we address the challenges of the COVID-19 pandemic, protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA. Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page. Updates May 6, 2021 - FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of 'Healthy' Symbols on Food Products May 5, 2021 - Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations May 4, 2021 - Medical Device Shortages During the COVID-19 Public Health Emergency May 4, 2021 - Coronavirus (COVID-19) Update April 30, 2021 - Coronavirus (COVID-19) Update April 30, 2021 - FDA Approves Treatment for Chronic Kidney Disease Webinars and Virtual Workshops May 11-12, 2021: Science Advisory Board to the National Center for Toxicological Research 2021 Meeting Announcement FDA announces a forthcoming virtual public advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research. The general function of the committee is to provide advice and recommendations to the Agency on research being conducted at the National Center for Toxicological Research (NCTR). At least one portion of the meeting will be closed to the public. May 11 - 12, 2021 Day 1: Tue, May 11, 2021; 9:00 AM - 6:55 PM ET Day 2: Wed, May 12, 2021; 9:00 AM - 12:30 PM ET Attend Online May 11-12, 2021: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting Announcement On May 11, 2021, the subcommittee will discuss the development and successful implementation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) as a tool for eliciting the patient's voice in oncology clinical trials to more accurately determine tolerability and toxicity of drugs under investigation. The subcommittee will also address the challenges of capturing this type of data across the age spectrum of the pediatric population and possible generalizability of data. May 11 - 12, 2021; 10:00 AM - 5:00 PM ET Registration is not required Project Orbis: Global Collaborative Oncology Review Program FDA Oncology Center of Excellence (OCE) launched Project Orbis in May 2019 with international regulatory authorities as a global collaborative review program for oncology marketing applications. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. The program aims to facilitate the submission, review, and approval of high impact oncology marketing applications across the participating countries. May 13, 2021; 12:00 PM - 1:00 PM ET Register Here FDA and Health Canada Regional ICH Consultation FDA and Health Canada will be co-hosting a regional public meeting to provide information and receive comments on current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) efforts and anticipated future topics. The public meeting will include discussion of harmonization guidelines reaching significant ICH milestones and other topical issues. Issues to be discussed will include good clinical practice principles, lifecycle management, model-informed drug development, and patient-focused drug development. May 14, 2021; 1:00 PM - 4:00 PM ET Register Here Public Web Conference to Provide Progress Update on ICH E6 Guideline for Good Clinical Practice The International Council for Harmonisation (ICH) members, including the FDA, the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Association, will hold a free public web conference on May 18 and 19 to provide a status update on revisions to the ICH E6 Guideline for Good Clinical Practice. This conference will consist of two similar meetings on May 18 and May 19 that will be held by the Expert Working Group (EWG) and convened by the Clinical Trials Transformation Initiative (CTTI). Individuals do not need to attend both days of the conference, although they are welcome to do so. The same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English. Day 1:Tue, May 18, 2021; 8:00 AM - 11:00 AM ET Day 2: Wed, May 19, 2021; 5:00 AM - 8:00 AM ET Registration To register and receive a link to the meeting, individuals should select the date that they plan to attend.  Day 1 Registration Day 2 Registration Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021 The Food and Drug Administration will hold the Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021. This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and the FDA. May 18, 2021; 1:00 PM - 4:00 PM ET May 19, 2021; 10:00 AM - 1:00 PM ET Register Here ICYMI! (In Case You Missed It!) Safely Using Hand Sanitizer   Some hand sanitizers have potentially toxic types of alcohol. Check FDA's do-not-use list at www.fda.gov/handsanitizerlist to learn more. Need help now? Call 911 if the person is unconscious or has trouble breathing. Call the Poison Help Line at 1-800-222-1222 to connect to your local poison center. We can help stop the spread of COVID-19 by washing our hands regularly with soap and water for 20 seconds – especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing our nose. If soap and water are not available, the Centers for Disease Control and Prevention recommend using alcohol-based hand sanitizers containing at least 60% alcohol to help you avoid getting sick and spreading germs to others. Read More About Us The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.

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