Updates Guidance Documents - Request for Comment Field Alert Report Submission: Questions and Answers Guidance This guidance provides FDA's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA's recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions. Consumer Updates Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek emergency medical help immediately. The U.S. Food and Drug Administration urges parents and caregivers to take precautions and make sure that these patches are stored, used, and disposed of properly. Below are some ways to reduce the risk of exposure and safely dispose of these patches, and what to do if a child is exposed to a fentanyl patch. FDA Voices FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative By: Andrea C. Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs Patients are at the heart of the U.S. Food Drug Administration's mission. Understanding patients' experiences is critical to support medical product regulation and help ensure safe, effective and innovative medical products are available. Learning from patients helps the agency uphold its public health mission. The FDA announced the call for applications for the next cohort of the Patient Engagement Collaborative (PEC). The PEC, established in 2018 in collaboration with the Clinical Trials Transformation Initiative (CTTI), is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. CTTI and the FDA collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations. The PEC is run by the FDA's Patient Affairs staff, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA. FDA's Budget: Medical Device Supply Chain and Shortages Prevention Program By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs The U.S. Food and Drug Administration's Devices Program is responsible for the regulation and oversight of a wide range of medical devices that patients and their health care providers use every day. These devices range from simple tongue depressors to complex instruments that help save and sustain life, such as heart valves, the artificial pancreas, and programmable pacemakers with micro-chip technology. Throughout the COVID-19 public health emergency, the FDA has taken many actions to help ensure that patients and health care providers have timely and continued access to high-quality medical devices. One such action was implementation of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law on March 27, 2020, and gave the FDA, for the first time, statutory authority intended to help prevent or mitigate device shortages during, or in advance of, a public health emergency. However, the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the U.S. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components. The FDA recognizes that this will take resources and expanded authority. Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines By: Sandra Kweder, M.D., Deputy Director of the Europe Office, Office of Global Policy and Strategy; LCDR Shannon Thor, Pharm.D., Europe Office, Office of Global Policy and Strategy; Kaveeta Vasisht, M.D., Pharm.D., Associate Commissioner for Women's Health; Lynne Yao, M.D., Director of Pediatric and Maternal Health, Center for Drug Evaluation and Research; Darcie Everett, M.D., M.P.H., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research. Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the U.S. Food and Drug Administration and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations. ICYMI! Always Tired? You May Have Sleep Apnea Do you feel tired or have a headache when you wake up in the morning? Something might be going wrong while you sleep that you don't know about: obstructive sleep apnea (pronounced app-nee-uh). What is Obstructive Sleep Apnea? The Greek word "apnea" means "without breath." An apnea is defined as a pause in breathing for at least 10 seconds. Obstructive sleep apnea, also called OSA, causes you to stop breathing in your sleep for several seconds, up to many times an hour. People diagnosed with OSA have at least five breathing pauses an hour and can have many more. During these breathing pauses, your brain, heart, kidneys, and other essential organs do not get enough oxygen, and carbon dioxide can build up in your body. When your brain notices there is not enough oxygen and too much carbon dioxide in your body, it sends out a signal to take a breath. You wake up enough to take a few breaths, but not enough to remember it the next morning. This cycle repeats itself many times each night, making you feel tired or exhausted in the morning. Webinars and Virtual Workshops Webinar - Remanufacturing of Medical Devices Draft Guidance and Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices Discussion Paper As part of the FDA's ongoing effort to provide consistency and better understanding of applicable statutory and regulatory requirements for medical device remanufacturing and servicing, this webinar is intended to clarify the activities that are likely "remanufacturing" of a device and cybersecurity issues that are unique to the servicing of medical devices. July 27, 2021; 1:00 PM - 2:30 PM Registration is not required. Webinar on Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance FDA will host a webinar for stakeholders interested in learning about the final guidance on Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations. July 29, 2021; 11:00 AM - 12:30 PM ET Registration is not required. FDA Oncology Center of Excellence Presents: Conversation on Cancer: Advancing Equity in Asian American and Pacific Islander (AAPI) Communities: Racism and Injustice
A conversation that will explore the surge of racism and hate crimes against AAPIs that is often linked to rhetoric blaming AAPIs for the spread of COVID-19. July 29, 2021; 2:00 PM - 3:30 PM 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. Did someone forward you this email? Sign up below! |
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