FDA Stakeholder Update - March 19, 2021

March 19, 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 March 17, 2021 - FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process March 17, 2021 - FDA Requires Four E-Cigarette Brands to Provide Critical Information on Social Media Practices March 16, 2021 - Coronavirus (COVID-19) Update March 16, 2021 - Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs March 16, 2021- FDA Investigates Source of Non-Viral Hepatitis Cases Possibly Linked to Bottled Alkaline Water March 15, 2021 - FDA Advises Patients, Caregivers and Providers of Risk of Breakage of Total Ankle Replacement Device March 15, 2021 - FDA Provides Updates on Adverse Event Reports Associated with Essure Permanent Birth Control March 12, 2021 - Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers   FDA Voices FDA's Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs and Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs Over the past year, the FDA's approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce, and the workforces of those we regulate. [3/18/2021] Read More FDA's Partnership with Mexico's Regulators Strengthens Food Safety Protections By: Donald Prater, Associate Commissioner for Imported Food Safety; Julie Moss, Director of the International Affairs Staff in the Center for Food Safety and Applied Nutrition; and Katherine Serrano, Director of the Latin America Office As the food supply becomes increasingly global, the FDA's partnerships with our regulatory counterparts and food producers in other nations are more important than ever. The work that the FDA has done in collaboration with the government and food industry in Mexico shows how much we can accomplish for the good of all our consumers when we work together. [3/17/2021] Read More Leveraging Real World Evidence in Regulatory Submissions of Medical Devices By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and Daniel Caños, Ph.D., M.P.H., Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH Among the many ways that the FDA protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation. For sponsors of medical products, providing data from prospective randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of a regulated product. However, for many medical devices, practical limitations related to the device or disease condition require alternative approaches to prospective randomized controlled trials and increased flexibility in trial design and statistical analysis. [3/16/2021] Read More Webinars and Virtual Workshops General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement The FDA announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. March 23, 2021; 9:00 AM - 6:00 PM ET Registration is not required. Roadmap to 2030 for New Drug Evaluation in Older Adults This workshop will bring together stakeholders from academia, industry, and regulatory agencies in a virtual setting to discuss the current status of inclusion of older adults in clinical trials and strategies to ensure the safe and effective use of drugs in this population March 23, 2021; 10:00 AM - 4:30 PM ET Register Here Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. March 24 - 25, 2021; Day 1: 9:00 AM - 4:30 PM ET, Day 2: 10:00 AM - 1:00 PM ET Registration is not required. Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Public Workshop The workshop will include presentations on nitrosamines chemistry and toxicology and, on the finding of nitrosamines as impurities in drugs. The presentations will be followed by open discussion of questions prepared by the FDA and presented to expert panelists for deliberations over 2 days. March 29 - 30, 2021; Day 1: 9:00 AM - 2:45 PM ET, Day 2: 9:00 AM - 2:30 PM ET                Registration is required for online attendance and will be available until 4PM ET on March 26, 2021. Register Here Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups This conference will provide guidance on the steps and potential pitfalls of early drug development for anticancer therapies. March 30 - 31, 2021; Day 1: 9:00 AM - 4:30 PM ET, Day 2: 9:00 AM - 4:30 PM ET  Register 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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