.betterdocs-breadcrumb-item.current span { Sunserra Clubhouse img.emoji { Whether it's a concert at the Gorge Amphitheater, a vineyard shuttle to local wineries, or just a group celebration, you can have fun getting there -- and back! Alaska Airlines, Inc. offers flights from Seattle Airport to Wenatchee Airport. Wearing a face mask on public transport in The Gorge Amphitheatre is recommended. } margin-bottom: 20px; switch ( type ) { .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list .docs-sub-cat li a:hover { color: #566e8b; padding-right: 15px; The HOA recommends giving you key or entry code to a trusted friend or neighbor in case of an emergency on your property. Rome2rios travel guides to the US tell you the best ways to explore the country, from Amtrak to Greyhound to the New York Subway. Welcome to the new HOA website. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) | CBER-Regulated Biologics, Contacts for Questions About Product Development, CBER-Regulated Therapeutics and the Coronavirus Treatment Acceleration Program (CTAP), Coronavirus Treatment Acceleration Program, Recommendations for Investigational COVID-19 Convalescent Plasma, Emergency Use Authorizations for Vaccines to Prevent COVID-19, FDAs Vaccine and Related Biological Products Advisory Committee, COVID-19 Resources for Healthcare Professionals, Coronavirus (COVID-19) and Medical Devices, Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions, Supporting product development and scaling up of manufacturing capacity for high priority products for COVID-19, Helping to ensure an adequate blood supply in light of reduced blood donations due to social distancing and the cancellation of blood drives, Providing information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products for patients with COVID-19, When a CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Centers review of the scientific data and information supporting our recommendation to issue the EUA, When an EUA is revised, we also intend to make public the Centers review of the scientific data and information supporting our recommendations to revise the EUA, Conduct of Clinical Trials involving Medical Products. Investigational mRNA vaccine against SARS-CoV-2 in development for the full breadth of COVID-19 vaccines Coronavirus! .pro-layout-4.single-kb .docs-cat-list-2-box-content .docs-cat-title { * } a.async = 1; Seating is limited. We encourage applicants to submit any questions to CBEREUA@fda.hhs.gov. document.addEventListener( 'DOMContentLoaded', ready, false ); Am I allowed to travel from Seattle to The Gorge Amphitheatre? /** var rendered1 = canvas.toDataURL(); At just a few minutes away from the Gorge, Sunland is the premier choice for accommodations. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency's advisory committee to . We supply the driver so you can enjoy the tour. The docket will close on October 15, 2020. .betterdocs-category-box.single-kb.ash-bg .docs-single-cat-wrap { color: #566e8b; Sunland is an oasis of a waterfront community nestled along the Columbia river in the shadow of towering basalt cliffs. * @param {number[]} set2 Set of Emoji character codes. width: 1em !important; context || ! font-size: 16px; isIdentical; padding-bottom: 130px; Rome2rio is a door-to-door travel information and booking engine, helping you get to and from any location in the world. .betterdocs-categories-wrap.single-kb .docs-sub-cat-title a:hover { Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Presentation- Booster Protection against confirmed infections and severe disease- data from Israel, CBER . } padding-top: 20px; .betterdocs-categories-wrap.single-kb .docs-item-container .docs-sub-cat-title { Find all the transport options for your trip from Seattle to The Gorge Amphitheatre right here. margin-bottom: 15px; padding-top: 30px; border-color: #528fff; .betterdocs-sidebar-content.betterdocs-category-sidebar .betterdocs-categories-wrap li a { settings.readyCallback = function() { case 'flag': Or seldom-used symbols Office of vaccines for COVID-19 is the only EV cber fda covid presentation with approved. .betterdocs-toc > .toc-title { } margin-bottom: 5px; We supply the driver so you can enjoy the tour. width: 320px; var canvas = document.createElement( 'canvas' ); color: #566e8b; } Follow us on GETTR. .betterdocs-search-heading h2 { * support settings accordingly. * */ padding-left: 20px; color: #444444; .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list .docs-sub-cat li a { .betterdocs-searchform svg.docs-search-icon { color: #566e8b; margin-top: 0px; 1 TNX-102 SL is an investigational new drug and has not been approved for any indication. font-size: 15px; border-bottom-left-radius: 50px; font-size: 12px; margin-left: 10px; } settings.supports.flag; min-width: 16px; $125/hour with a minimum booking of 4 hours. } } At this year's 2015 DIA Annual Meeting in Washington, DC, FDA representatives from . color: #566e8b; The Gorge Amphitheatre is a 27,500-seat outdoor concert venue near the Columbia River in George, Washington managed by Live Nation. .betterdocs-live-search .docs-search-result li { We have licensed, CDL drivers to safely get you there and back, too. */ @font-face{font-family:eicons;src:url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.eot?5.10.0);src:url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.eot?5.10.0#iefix) format("embedded-opentype"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.woff2?5.10.0) format("woff2"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.woff?5.10.0) format("woff"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.ttf?5.10.0) format("truetype"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.svg?5.10.0#eicon) format("svg");font-weight:400;font-style:normal} Sunland is an amazing oasis of a community. } .betterdocs-credit p{ We're working around the clock to bring you the latest COVID-19 travel updates.This information is compiled from official sources. margin-right: 0px; (function() { fill: #566e8b; } Please note that late, untimely filed comments will not be considered. Submit electronic comments in the following way: Written/Paper Submissions Learning Objectives. * padding-bottom: 50px; Our mission is to provide you with knowledge and options in the care of your animal. background: none !important; An amended notice was published to announce a new meeting webcast link (see webcast information) and public participation information has been changed to include a docket for written comments. img.wp-smiley, background-color: #fff; color: #201d3a; .docs-search-close path.close-border { On October 22, 2020, oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. EST. } padding-bottom: 0px; */ margin-bottom: 10px; Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. margin-bottom: 20px; border-color: #528ffe; The road distance is 241.2 km. FDA intends to make background material available to the public no later than 2 business days before the meeting. Center for Biologics Evaluation and Research plans for monitoring COVID-19 vaccine safety and effectiveness Personal Author: . * To test for support, we try to render it, and compare the rendering to how it would look if } Don't delay, the shuttles fill up fast! Please note that for products under CBERs jurisdiction, submission to the CTAP mailbox helps to facilitate identification and assignment to the appropriate review office within our Center so that your inquiry gets to the right subject matter experts quickly. }.secondary-menu-wrap .menu-icons > li > a, .secondary-menu-wrap .secondary-menu > li > a { padding-top: 10px; Director, Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research (CBER) gave a presentation on CBER "Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness". 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