FDA Stakeholder Update - June 11, 2021

June 11, 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 June 10, 2021 - The President's FY2022 Budget Request for FDA June 10, 2021 - Medical Device Shortages During the COVID-19 Public Health Emergency June 10, 2021 - Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel June 9, 2021 - FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials June 8, 2021 - Coronavirus (COVID-19) Update June 7, 2021 - FDA Grants Accelerated Approval for Alzheimer's Drug June 7, 2021 - Cybersecurity: NIST Request on Presidential Executive Order: Comments Submitted by the FDA Guidance Documents - Request for Comment Core Patient-Reported Outcomes in Cancer Clinical Trials This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials. Submit Comments Spotlight! FDA's Center for Drug Evaluation and Research announced an updated online continuing education (CE) course titled "FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond." The revised course provides an overview of the FDA drug regulatory process and the science that supports the FDA mission. The course provides 1.5 hours of free continuing education credit to health care providers about the basics of the FDA drug regulatory process and the science that supports this mission in CDER. It will also educate the nation's health care providers about their role in communicating drug information to their patients. Launch Course ICYMI! Innovative Regenerative Medicine Therapies – Patient Safety Comes First By: Peter Marks, M.D., Director, Center for Biologics Evaluation and Research The U.S. Food and Drug Administration continues to facilitate the development and availability of innovative medical products, such as regenerative medicine therapies, that have the potential to treat or even cure diseases or conditions for which few effective treatment options exist. For example, the agency has recently licensed (approved) its first product that received Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring our ongoing commitment to work with sponsors and manufacturers to bring these products to market. Read More FDA's Oncology Center of Excellence Launches National Black Family Cancer Awareness Week By: Richard Pazdur, M.D., Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE  The U.S. Food and Drug Administration's Oncology Center of Excellence (OCE) is announcing its inaugural National Black Family Cancer Awareness Week (NBFCAW), which will take place from June 17 through June 23, 2021. Throughout the week, the agency's social media platforms will serve as the hub for this historic initiative as participants at health care centers, non-profit associations, and community organizations nationwide raise awareness about the impact of cancer on Black families. Research has shown that cancer awareness can help lower cancer mortality rates and increase life expectancy for all racial and ethnic groups, including Black Americans. Read More Webinars and Virtual Workshops FDA-Arthritis Foundation Osteoarthritis Drug Development Workshop: Assessment of Long-term Benefit The FDA and the Arthritis Foundation (AF) have joined forces for this workshop to leverage their combined strengths to bring together subject matter experts in the field of diagnosis, research, development, and treatment of OA. The goal of this workshop is to provide a forum for continued open discussion between leading osteoarthritis experts in academia, industry, the non-profit sector, and government, with the ultimate goal of expediting the development of safe and effective treatments intended to provide long-term benefit in OA. June 22, 2021; 10:00 AM - 5:00 PM ET Register Here FY 2021 Generic Drug Science and Research Initiatives Public Workshop The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA's commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Initiatives. June 23, 2021; 8:00 AM - 4:30 PM ET  Register Here Working Together - Keeping Informed: FDA Medical Device Virtual Conference 2021 This one-day virtual conference, hosted by the Office of Medical Device and Radiological Health Operations, offers representatives of registered firms with the Food and Drug Administration (FDA) to learn about current FDA operations.  June 23, 2021; 10:30 AM - 5:00 PM ET Register Here Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement The committee will discuss biologics license application (BLA) 761209, for retifanlimab injection, submitted by Incyte Corporation. The proposed indication (use) for this product is for the treatment of adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy. June 24, 2021; 10:30 AM - 2:30 PM ET Registration is not required. Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment FDA will host a webinar to share information and answer questions about the final guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This guidance document provides the FDA's recommendations on testing to assess the safety and compatibility of medical devices in the MR Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital. June 24, 2021; 11:00 AM - 12:30 PM ET Registration is not required. 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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