Updates Consumer Updates Tianeptine Products Linked to Serious Harm, Overdoses, Death  People seeking to treat their ailments sometimes mistake a product as being safe because it's easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks and even death. Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use. Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers. They are also making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions. Medical Device Cybersecurity: What You Need to Know  Pacemakers, insulin pumps and other medical devices are becoming more advanced. Most contain software and connect to the internet, hospital networks, your mobile phone, or other devices to share information. Because of this, it is important to make sure medical devices are cyber secure. New technologies are being applied to all different types of devices—those that are implantable or wearable or used at home or in health care settings. The advances can offer care that is safer, more timely and more convenient. For example, patients with an implanted heart device can be monitored remotely, potentially reducing the number of visits to the doctor's office. People with diabetes have new options for managing their blood-sugar levels because some glucose meters and insulin pumps can essentially talk to each other. Hospitals aiming to improve care and efficiency are using more devices that are networked together to share data. ICYMI! Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments  While we remain vigilant to protect our families and communities from COVID-19, some people might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent coronavirus disease. Vaccination is one of the best ways to protect everyone who is eligible from COVID-19. The U.S. Food and Drug Administration has approved two vaccines for the prevention of COVID-19 and issued emergency use authorizations (EUAs) for others. For the latest information on COVID-19 vaccines, visit this FDA page. Webinars and Virtual Workshops Public Meetings on the Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule February 14, 2022; 11:45 AM - 7:45 PM ET The U.S. Food and Drug Administration (FDA) will be holding two virtual public meetings on the recently released proposed rule "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water." The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule. Minority Health and Health Equity - Promoting Clinical Trial Diversity for Racial and Ethnic Minority Populations Living with Diabetes February 15, 2022; 2:00 PM - 3:00 PM ET  In honor of Black History Month, the FDA Office of Minority Health and Health Equity (OMHHE) will host a webinar featuring Dr. Shanta Whitaker, Senior Director, Policy, Advocacy, and Communications, at the American Diabetes Association. CDER BIMO GCP Compliance and Enforcement February 16, 2022; 1:00 PM - 3:30 PM ET This webinar will: - Provide a general overview of the Bioresearch Monitoring (BIMO) program
- Discuss Good Clinical Practice (GCP) inspectional processes, compliance evaluation and enforcement, including case examples
- Summarize findings from a recent publication on follow-up inspectional activities after FDA notifies an inspected entity of serious-noncompliance
- Include live Q&A session and a moderated panel discussion
Collaborating on Culture in the New Era of Smarter Food Safety February 16, 2022; 12:30 PM - 1:15 PM ET The U.S. Food and Drug Administration and Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture, one of the core elements in FDA's New Era of Smarter Food Safety initiative. Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices February 22, 2022; 1:00 PM - 2:30 PM ET The U.S. Food and Drug Administration (FDA) will host a webinar for stakeholders interested in learning more about the draft guidances on COVID-19 transition plans for medical devices. This webinar will: - Help prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations
- Describe recommendations regarding submitting a marketing submission and the timeline for doing so
- Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline
- Answer your questions about the draft guidances on COVID-19 transition plans
Registration is not required. Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA February 24, 2022; 1:00 PM - 3:00 PM ET In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency's recommendations regarding BE information submitted in an Abbreviated New Drug Application (ANDA) submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines. This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket. Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance March 1, 2022; 1:00 PM - 2:30 PM ET The U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss and answer questions about the final guidance: Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. This guidance outlines recommended best practices to help ensure relevant, reliable, and sufficiently robust patient-reported outcome instruments are developed, modified, or adapted using the least burdensome approach. Registration is not required. Public Meeting: FDA Rare Disease Day 2022 March 4, 2022; 9:00 AM - 4:30 PM ET  FDA will host a virtual public meeting on March 4, 2022 to join the global observance of Rare Disease Day. The theme for FDA's Rare Disease Day is "Sharing Experiences in Rare Diseases Together." Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development. About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! | 
No comments:
Post a Comment