FDA Stakeholder Update - January 29, 2021

January 29, 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 January 27, 2021 - FDA Warns Company for Putting Consumers at Risk through Distribution of Non-Compliant and Misbranded Drug Ingredients January 26, 2021 - Coronavirus (COVID-19) Update January 26, 2021 - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers January 22, 2021 - Coronavirus (COVID-19) Update FDA Insight Join FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics. Webinars and Virtual Workshops Webinar - Safer Technologies Program: Final Guidance FDA will host a webinar on the Safer Technologies Program for industry and other stakeholders interested in learning more about the Program and final guidance. February 1, 2021; 12:00 PM - 1:30 PM ET Registration is not required. Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting This meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant people in clinical trials for drug development. February 2 - 3, 2021; 12:00 PM - 3:00 PM ET Register for this event here. FDA-ASCO Virtual Workshop Defining a Research Agenda to Address Barriers and Solutions to Oral Anticancer Agent Adherence The FDA and American Society of Clinical Oncology (ASCO) have collaborated to leverage their combined strengths for the joint development of the substantive actions of this workshop to explore: Factors contributing to non-adherence to oral anticancer agents. Potential solutions and approaches to improving oral anticancer agent adherence. Gaps in knowledge, and future research questions regarding non-adherence to oral anticancer agents.  February 2 - 3, 2021; Day 1: 1:00 PM - 4:30 PM ET, Day 2: 1:00 PM - 5:30 PM ET  Register for this event here. Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement The committee will discuss supplemental biologics license application (sBLA) 125514/s-089, for KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. February 9, 2021; 10:00 AM - 2:00 PM ET  Registration is not required. SHIP-MD Virtual Public Workshop – Pediatric Medical Devices Through a cooperative agreement with the Critical Path Institute (C-Path), the FDA Center for Devices and Radiological Health (CDRH) is announcing a 3-day virtual public workshop, System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) 2021 Virtual Workshop. The purpose of this workshop is to bring together stakeholders interested in pediatric medical device development to review, discuss, and gather feedback on the strategic framework for SHIP-MD. Free registration will be available up to the workshop. February 9 - 11, 2021; 10:00 AM ET – 1:00 PM ET Register for this event here. Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.  February 16 - 17, 2021; Day 1: 1:00 PM - 5:00 PM ET, Day 2: 1:00 PM - 3:30 PM ET  Register for this event here. Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) catheter.  February 17, 2021; 9:00 AM - 6:00 PM ET Registration is not required. Conversations on Cancer Black History Month Panel Discussion, "Living with Cancer While Black Clinical Trial Barriers, Part Two" Does a Black cancer patient have equal access to clinical trial participation? How is a patient's cancer treatment and chance of survival different if they are a Black American? What actions can we each take to contribute to greater equity in the treatment of all Americans with cancer? Be sure to join this lively Oncology Center of Excellence panel discussion.  February 18, 2021; 1:00 PM - 2:30 PM ET Register for this event here. FDA Safety Report Type Flag Requirement for FAERS Submissions FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement. February 19, 2021; 1:00 PM - 2:00 PM ET Register for this event here. 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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