September 30, 2022 at 09:20PM Biological Product Deviation Reporting -- Blood Product Codes

This is the main page for the Biological Product Deviation Reporting - Blood Product Codes.

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September 30, 2022 at 08:40PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/ftCsWlT) to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

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September 30, 2022 at 04:09PM Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

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September 30, 2022 at 04:08PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

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September 29, 2022 at 08:14PM Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement - 10/06/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement.

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September 29, 2022 at 08:03PM Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7

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September 28, 2022 at 10:02PM Clinical Guidances

This page lists Clinical Guidance documents.

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September 28, 2022 at 02:05AM 2022_09 Test Article EDITED FT 02

2022_09 Test Article some long description some long description.

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September 27, 2022 at 10:18PM ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

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September 27, 2022 at 05:04PM Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement - 02/26/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement.

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September 27, 2022 at 04:59PM 2016 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for CBER's 2016 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

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September 22, 2022 at 06:52PM Clinical Decision Support Software

This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.

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September 26, 2022 at 03:27PM WHO Committees and Networks

CBER staff contribute as subject matter experts on WHO Advisory Committees sharing scientific and regulatory expertise on issues within CBER’s regulatory purview.

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September 23, 2022 at 03:32PM Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Clinical / Medical

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September 22, 2022 at 10:06PM Essential Regulatory Laboratory Activities

CBER is an Essential Regulatory Laboratory (ERL) in WHO’s Global Influenza Surveillance and Response System (GISRS) in collaboration with the United Kingdom, Australia, and Japan regulatory authorities.

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September 22, 2022 at 09:53PM Gardasil Vaccine Safety

Gardasil vaccine safety monitoring activities and findings as reported by FDA and CDC.

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September 22, 2022 at 09:51PM WHO Vaccine Prequalification Program

The WHO, through the Quality Safety and Standards (QSS) Unit of the Department of Immunization, Vaccines and Biologicals (IVB), provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. The WHO does so through its vaccine prequalification program.

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September 21, 2022 at 11:23PM Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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September 22, 2022 at 06:15PM Guidances, Federal Register Notices & Standard Operating Policy & Procedure for Advertising & Promotional Labeling

Guidances, Federal Register Notices & Standard Operating Policy & Procedure for Advertising & Promotional Labeling

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September 22, 2022 at 05:31PM Bovine Spongiform Encephalopathy (BSE) Questions and Answers

Bovine Spongiform Encephalopathy (BSE) Questions and Answers

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September 22, 2022 at 04:37PM Thimerosal and Vaccines

Thimerosal is a compound that has been widely used as a preservative in a number of biological and drug products. All vaccines routinely recommended for children 6 years of age and younger in the U.S. are available in formulations that do not contain thimerosal. The use of thimerosal as a preservative in vaccines has declined due to reformulation and development of new vaccines in single-use presentations.

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September 21, 2022 at 03:19PM Rare Diseases at FDA

The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development.

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September 21, 2022 at 08:38PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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September 21, 2022 at 03:09PM Advisory Committees Give FDA Critical Advice and the Public a Voice

Not familiar with FDA’s advisory committees? These committees provide independent, expert advice to the FDA on a range of complex scientific, technical and policy issues related to the development and evaluation of FDA-regulated products.

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September 21, 2022 at 02:49PM Electronic Submission Template for Medical Device 510(k) Submissions

This guidance provides further standards for electronic 510(k) submission, a timetable for establishment of the standards, and criteria for waivers/exemptions.

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September 21, 2022 at 12:39AM Computationally Engineered Anti-SARS-CoV-2 Monoclonal Antibodies with High Binding Affinities

Computationally Engineered Anti-SARS-CoV-2 Monoclonal Antibodies with High Binding Affinities

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September 20, 2022 at 10:22PM Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement - 09/17/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement.

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September 20, 2022 at 02:07PM Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP).

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September 19, 2022 at 09:02PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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September 16, 2022 at 07:58PM Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy

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September 16, 2022 at 06:51PM Live attenuated SARS-CoV-2 vaccine candidate adaptable to emerging SARS-CoV-2 variants

Live attenuated SARS-CoV-2 vaccine candidate adaptable to emerging SARS-CoV-2 variants

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September 16, 2022 at 04:17PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

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September 15, 2022 at 09:50PM OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls - 09/29/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls. This event is the first in a series to answer questions from stakeholders about a variety of topics.

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September 15, 2022 at 06:57PM MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

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September 15, 2022 at 06:48PM MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

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September 15, 2022 at 05:46PM Instructions for Completing Form FDA 3500

Instructions for Completing Form FDA 3500

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September 13, 2022 at 11:20PM FDA Patient Engagement Overview*

FDA Patient Engagement Overview

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September 13, 2022 at 11:10PM FDA Patient Engagement Opportunities

A description of some of the opportunities for patients, caregivers and advocates to engage with the FDA.

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September 14, 2022 at 04:54PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

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September 14, 2022 at 04:05PM FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

FDA and NIH launch Critical Path for Rare Neurodegenerative Diseases – a public-private partnership aimed at advancing the understanding of rare neurodegenerative diseases and fostering the development of treatments.

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September 14, 2022 at 02:45PM Q3D(R2) – Guideline for Elemental Impurities

International Council for Harmonisation; Draft Guidance for Industry

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September 13, 2022 at 08:47PM Devices Guidances

This page lists Medical Device Guidance documents.

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September 12, 2022 at 08:24PM RAGWITEK

Product approval information for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen approved for use in adults 18 through 65 years of age.

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September 12, 2022 at 04:57PM GRASTEK

Product approval information for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age

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September 12, 2022 at 03:38PM Emergency Use Authorization of Medical Products and Related Authorities

ProceduralGuidance - Emergency Use Authorization of Medical Products - Explains FDA's general recommendations and procedures applicable to authorization of the emergency use of certain medical products under the FD&C Act, as amended or added by PAHPRA.

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September 09, 2022 at 10:09PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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September 09, 2022 at 04:09PM Administrative Guidances

This page lists Administrative Guidance documents.

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September 08, 2022 at 11:57PM Respuesta de la FDA a la viruela del mono

Respuesta de la FDA a la viruela del mono

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September 08, 2022 at 08:11PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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September 08, 2022 at 06:34PM Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement - 09/22/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement.

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September 08, 2022 at 02:32PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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September 07, 2022 at 04:49PM Cleared 510(k) Submissions with Supporting Documents

Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.

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September 07, 2022 at 02:10PM Consumer Updates

Science-based health and safety information you can trust.

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September 06, 2022 at 04:18PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

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UK weighs huge support package as Europe battles energy crisis - Reuters

1. UK weighs huge support package as Europe battles energy crisis  Reuters
2. How European states want to tackle the energy crunch | DW News  DW News
3. Energy Trade Risks Collapsing Over Margin Calls of $1.5 Trillion  Bloomberg
4. Editorial: A new outbreak of energy hostilities in Europe could be felt here  New Zealand Herald
5. EU races to shield industry as Russia gas stoppage shakes markets  Reuters
6. View Full Coverage on Google News

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EU races to shield industry as Russia gas stoppage shakes markets - Reuters

1. EU races to shield industry as Russia gas stoppage shakes markets  Reuters
2. As Russia Chokes Europe’s Gas, France Enters Era of Energy ‘Sobriety’  The New York Times
3. Can Europe's $375 Billion in Relief Keep Households Warm Enough?  Bloomberg
4. Editorial: A new outbreak of energy hostilities in Europe could be felt here  New Zealand Herald
5. Europe faces a 'winter of discontent' as the US profits from the energy crisis  Global Times
6. View Full Coverage on Google News

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EU races to shield industry as Russia gas stoppage shakes markets - Reuters

1. EU races to shield industry as Russia gas stoppage shakes markets  Reuters
2. As Russia Chokes Europe’s Gas, France Enters Era of Energy ‘Sobriety’  The New York Times
3. Can Europe's $375 Billion in Relief Keep Households Warm Enough?  Bloomberg
4. Editorial: A new outbreak of energy hostilities in Europe could be felt here  New Zealand Herald
5. Power producers call for collateral change to avert 'Lehman' moment  Financial Times

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Millions in China under COVID lockdown restrictions - Fox News

1. Millions in China under COVID lockdown restrictions  Fox News
2. China locks down 21 million people in Chengdu as COVID-19 cases rise  Al Jazeera English
3. Chinese cities rush to lockdown in show of loyalty to Xi's 'zero-Covid' strategy  CNN
4. China’s Chengdu Extends Covid-19 Stay-Home Order as Restrictions Test Economy  The Wall Street Journal
5. China's Guiyang Locks Down Some Areas to Contain Covid Outbreak  Bloomberg

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Millions in China under COVID lockdown restrictions - Fox News

1. Millions in China under COVID lockdown restrictions  Fox News
2. Chinese cities rush to lockdown in show of loyalty to Xi's 'zero-Covid' strategy  CNN
3. China locks down 21 million people in Chengdu as COVID-19 cases rise  Al Jazeera English
4. China’s Chengdu Extends Covid-19 Stay-Home Order as Restrictions Test Economy  The Wall Street Journal
5. China's Guiyang Locks Down Some Areas to Contain Covid Outbreak  Bloomberg
6. View Full Coverage on Google News

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An E. coli outbreak possibly linked to Wendy's has expanded to six states - NPR

1. An E. coli outbreak possibly linked to Wendy's has expanded to six states  NPR
2. Wendy's E.coli outbreak SPREADS to New York and Kentucky after over 100 left sick  Daily Mail
3. E. coli outbreak extends to New York and Kentucky  NBC News
4. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
5. Multi-State E. Coli Outbreak Spreads To New York, Kentucky: CDC  TODAY
6. View Full Coverage on Google News

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E. coli outbreak extends to New York and Kentucky - NBC News

1. E. coli outbreak extends to New York and Kentucky  NBC News
2. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
3. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
4. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
5. Wendy's E. coli outbreak spreads to New York, Kentucky, CDC says  WTAJ News
6. View Full Coverage on Google News

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Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC - New York Post

1. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
4. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
5. Wendy's E. coli outbreak spreads to New York, Kentucky, CDC says  WTAJ News
6. View Full Coverage on Google News

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Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC - New York Post

1. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
4. Wendy's E. coli outbreak spreads to New York, Kentucky, CDC says  WTAJ News
5. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee

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An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states - CNN

1. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. Wendy's E. coli outbreak spreads to New York, Kentucky, CDC says  WTAJ News
4. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
5. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
6. View Full Coverage on Google News

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An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states - CNN

1. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
4. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
5. Wendy's E. coli outbreak spreads to New York, Kentucky, CDC says  WTAJ News

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An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states - CNN

1. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
4. Wendy's E. coli outbreak spreads to New York, likely more sick than reported: CDC  New York Post
5. Local woman sues Wendy's, lettuce supplier over alleged E.coli outbreak  WXYZ 7 Action News Detroit
6. View Full Coverage on Google News

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An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states - CNN

1. An E. coli outbreak associated with Wendy's restaurants has now sickened 97 people in 6 states  CNN
2. Wendy’s E. coli outbreak spreads to more states, including New York and Kentucky, CDC says  Fox Business
3. CDC investigates E. coli outbreak: 87% ate romaine lettuce in Wendy’s sandwiches  WISN Milwaukee
4. Local woman sues Wendy's, lettuce supplier over alleged E.coli outbreak  WXYZ 7 Action News Detroit
5. CDC says Wendy’s E. coli outbreak is now up to 6 states, including Pa. Here’s what to know.  The Philadelphia Inquirer

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September 02, 2022 at 09:23PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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September 02, 2022 at 08:25PM BK190338- ORTHO VISION® Analyzer

This is the CBER 510k BK190338 Letter- ORTHO VISION® Analyzer.

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Chinese metropolis of Chengdu locks down 21 million residents - CNN

1. Chinese metropolis of Chengdu locks down 21 million residents  CNN
2. Chengdu locks down 21.2 million people as Chinese cities battle Covid-19  CNBC
3. Chengdu locks down 21 million people in fresh Covid outbreak  The Guardian
4. In China, Some Cities Edge Into Covid-19 Lockdowns Ahead of Party Congress  The Wall Street Journal
5. China Locks Down Megacity Chengdu as Covid Zero Rolls On  Bloomberg
6. View Full Coverage on Google News

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Pakistan floods: The government and civilian volunteers work to deliver relief - NPR

1. Pakistan floods: The government and civilian volunteers work to deliver relief  NPR
2. Thousands Of Pakistan Flooding Survivors Are Suffering From Waterborne Illness  NBC News
3. How to help Pakistan  The Washington Post
4. Photos: Flood-hit Pakistan now fights waterborne diseases  Al Jazeera English
5. Outbreak of waterborne diseases hits areas of Pakistan devastated by record flooding  NBC News

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September 01, 2022 at 09:05PM BK180200: LifeTrak 2018

This is the CBER 510k BK180200: LifeTrak®2018.

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September 01, 2022 at 06:08PM Using A Whole-Of-Governments Approach to Combating Illicit Health Products

A whole-of-governments approach is the best way to protect the public health from the trade of illicit health products and the FDA will advocate for that approach.

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Health officials warn of major outbreaks of disease after severe floods in Pakistan - The Guardian

Health officials warn of major outbreaks of disease after severe floods in Pakistan  The GuardianView Full Coverage on Google News

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Chinese metropolis of Chengdu locks down 21 million residents - CNN

1. Chinese metropolis of Chengdu locks down 21 million residents  CNN
2. China Locks Down Megacity Chengdu as Covid Zero Rolls On  Bloomberg
3. China's Shenzhen widens COVID restrictions as cases rise  Reuters.com
4. China locks down 21 million in Chengdu in COVID-19 outbreak  The Washington Post
5. China places millions into Covid lockdown again as economy continues to struggle  The Guardian
6. View Full Coverage on Google News

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