Updates Consumer Updates Nitrite "Poppers" Ingesting or inhaling nitrite poppers can cause severe injury or death Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation of nitrite products for recreational use, including sexual experience enhancement.
Commonly referred to as "poppers," these products contain chemical substances similar to the prescription medication, amyl nitrite, which is prescribed for the relief of chest pain. However, poppers have not been evaluated by the FDA for safe use. These products are not safe to ingest or inhale. Learn More About COVID-19 Vaccines From the FDA The U.S. Food and Drug Administration has authorized three COVID-19 vaccines for emergency use. The vaccines are: Pfizer BioNTech COVID-19 Vaccine Moderna COVID-19 Vaccine Janssen (sometimes called Johnson & Johnson) COVID-19 Vaccine Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDA's Center for Biologics Evaluation and Research (CBER). 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. FDA Voices One Year Later, the New Era of Smarter Food Safety Blueprint Makes Inroads in FDA's Public Health Mission By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response One year ago today the U.S. Food and Drug Administration released the New Era of Smarter Food Safety Blueprint. During the past 12 months, we've made significant progress in working toward the goals outlined in the blueprint, even in the midst of a pandemic. The blueprint gives shape to the New Era of Smarter Food Safety initiative that the FDA announced in April 2019 to keep pace with the rapidly evolving environment in which foods are being reformulated, new foods and new production methods are being realized, and food delivery systems continue to evolve. FDA to Discuss COVID-19's Impact on Medical Product Operations at SBIA REdI Annual Conference By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs In the face of the COVID-19 pandemic, the U.S. Food and Drug Administration has worked hard to help facilitate the timely development of medical products. We have used our emergency authorities to make these products available to the public as soon as possible, provided the criteria for issuance are met. We have also kept our partners in public health — industry, health care providers, consumers, congressional leaders, and other stakeholders — updated of our actions and the decisions we have made throughout the pandemic. ICYMI! FDA's Budget: Data Modernization and Enhanced Technologies By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs The U.S. Food and Drug Administration's mission to protect and promote the public health impacts the life of every American, every day. Our work encompasses an ever-widening array of foods, additives, cosmetics, medicines, and medical devices as the FDA regulates approximately 20 cents of every dollar spent annually by American consumers. The industries we regulate are constantly innovating, attracting skilled professionals, and upgrading their technological capabilities. Webinars and Virtual Workshops FDA PUBLIC WORKSHOP: 6th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop The overarching aim of this year's workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. July 21 - 23, 2021 Day 1: Wednesday, July 21, 2021; 1:00 PM - 4:00 PM ET Day 2: Friday, July 23, 2021; 9:00 AM - 12:00 PM ET Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Celiac Disease The goal of the GREAT VI workshop is to discuss the overall approach to drug development in celiac disease that includes an assessment of both clinical symptoms and histology. The workshop will focus the discussion on the histologic endpoints to assess treatment benefit in patients with celiac disease; regulatory framework for pediatric drug development in celiac disease; and the role of gluten challenge in clinical trials to provide a forum for open discussion between stakeholders to facilitate drug development. July 22, 2021; 9:00 AM - 3:30 PM ET 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! |
No comments:
Post a Comment