Updates We Can Do This: COVID-19 Public Education Campaign An initiative to increase confidence in COVID-19 vaccines and reinforce basic prevention measures  About the Campaign The HHS COVID-19 public education campaign is a national initiative to increase public confidence in and uptake of COVID-19 vaccines while reinforcing basic prevention measures such as mask wearing and social distancing. Through a nationwide network of trusted messengers and consistent, fact-based public health messaging, the campaign helps the public make informed decisions about their health and COVID-19, including steps to protect themselves and their communities. The effort is driven by communication science and provides tailored information for at-risk groups. The COVID-19 Community Corps Our best path out of the COVID-19 pandemic is for every American to get a COVID-19 vaccination as soon as it's available to them. You're invited to support the effort by joining the COVID-19 Community Corps. As a member, you'll receive timely, accurate information to share with your family, friends, and neighbors. By encouraging them to get vaccinated, you'll help protect them – and allow all of us to safely gather together again. Additional Resources: We Can Do This: COVID-19 Public Education Campaign English COVID-19 Vaccine Resources Spanish COVID-19 Vaccine Resources Multilingual Resources & Toolkits Help FDA Prevent the Sale of Tobacco Products to Young People It's important to keep all tobacco products out of the hands of young people. Find out how you can help.  Many teens underestimate how easy it is to become addicted to nicotine. This raises concerns because young people are at greatest risk of nicotine addiction because their brains are still developing. In fact, as little as one cigarette a month is all it takes for some teens to show symptoms of addiction. And some vape cartridges can contain as much nicotine as an entire pack of cigarettes. It's important to keep all tobacco products out of the hands of young people. To protect the public health, the U.S. Food and Drug Administration regulates all tobacco products, including cigarettes, e-cigarette/vaping products, cigars, smokeless tobacco, hookah, and more. It is illegal to sell any tobacco product to anyone under the age of 21. To ensure tobacco product retailers follow all of the restrictions on the marketing and sale of tobacco products, the FDA monitors compliance through surveillance and inspections and by investigating complaints from the public about potential violations. Watch Out for False Promises on Some Dietary Supplements  You may know someone who has been unable to get pregnant due to infertility issues. According to the Centers for Disease Control and Prevention, about 12 percent of women aged 15 to 44 in the United States have difficulty becoming pregnant or carrying a pregnancy to term. "Fertility" Products Prey on Vulnerability Marketers are targeting this population by pitching dietary supplements that make unproven claims to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. Some women may have had difficulties conceiving or have underlying health conditions that put them at risk of infertility. 4 Medication Safety Tips for Older Adults Learn how to use medicines safely and avoid unwanted side effects and interactions as you age.  Whether you're settling into your sixties or heading into your nineties, be careful when taking prescription and over-the-counter medicines, herbal preparations, and supplements. And if you're caring for older loved ones, help them stay safe too. Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses  Sun safety is always in season. It's important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or "leathery skin"), eye damage, and skin cancer, the most common of all cancers. FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law Acting FDA Commissioner, Dr. Woodcock's Keynote Address  Watch Acting FDA Commissioner, Janet Woodcock, M.D. discuss FDA's strategic priorities at the FDLI Annual Conference. Guidance Documents - Request for Comments This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing: - an overview of section 522 of the FD&C Act;
- information on how to fulfill section 522 obligations, including:
- when postmarket surveillance should be considered commenced;
- recommendations for achieving an approved postmarket surveillance plan in a timely manner; and
- recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;
- recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and
- updated surveillance status categories to better reflect progress.
The purpose of this draft guidance document, when finalized, is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing: - procedural information;
- recommendations concerning the format, content, and review of PAS-related submissions; and
- updates to the final guidance entitled "Procedures for Handling Post-Approval Studies Imposed by PMA Order" dated June 2009, including:
- recommendations for study timelines including enrollment milestones and study completion;
- revised definitions to PAS status categories that we believe better reflect progress of the PAS; and
- revised FDA review time goals for PAS-related submissions.
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency. This document supersedes the guidance of the same title issued in February 2021 (which superseded the guidance of the same title issued October 2020). This guidance provides recommendations to assist industry and other stakeholders involved in the development of bispecific antibodies. In addition to general considerations, the guidance provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs. Although this guidance is intended for bispecific antibodies, the principles discussed in this guidance may also inform the development of other types of bispecific protein products and multispecific products. This guidance does not discuss development considerations for other multitarget therapies that are antibody cocktails, polyclonal antibody products, or combinations of monoclonal antibodies. Webinars and Virtual Workshops The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Neurological 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. The meeting will be open to the public. June 3 - 4, 2021; 9:00 AM - 6:00 PM ET Registration is not required. FDA will provide an overview of the Over-The-Counter Monograph Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees. June 3, 2021; 1:00 AM - 2:00 PM ET The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ''Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.'' The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications. June 7 - 8, 2021; 9:00 AM - 5:00 PM ET The purpose of this public workshop is to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD). June 9, 2021; 8:00 AM - 5:00 PM ET On June 9, 2021 the Food and Drug Administration (FDA) is conducting a public workshop entitled "The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021." The purpose of the public workshop is to evaluate the data and information currently available on consumer comprehension of the nonprescription Drug Facts Label (DFL) and to bring together stakeholders from the FDA, academia, and industry to discuss areas where improvements could be made to the format and content of the DFL. The DFL is intended to enable consumers to appropriately self-select and use nonprescription drug products safely and effectively. The FDA is seeking ways to optimize the DFL for consumer use so that it is robust, user-friendly, compatible with traditional text/paper-based presentation, and adaptable for use with new technologies. Registration is required for online attendance and will be available until 4:00 p.m. ET on Friday, June 4th, 2021. June 9, 2021; 8:30 AM - 4:30 PM ET The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. The chart below identifies the use(s) FDA reviewed for each of the four bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances or another interested party will be invited to make a short presentation supporting the nomination. Registration is not required. In this talk, Dr. Mark Dredze will discuss how online data can inform regulatory science. By mining existing online data sources, such as news media, web search trends and social media, emerging issues can be identified to ensure that regulations can be effective and responsive to the changing environment. June 9, 2021; 3:00 PM - 4:00 PM ET 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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