Tornadoes, Hail, 'Destructive' Wind Possible Friday As Storms Expected To Batter Chicago - Block Club Chicago

1. Tornadoes, Hail, 'Destructive' Wind Possible Friday As Storms Expected To Batter Chicago  Block Club Chicago
2. Severe Weather Outbreak Likely Across Central US With Multiple Strong Tornadoes Expected  FOX Weather
3. Tornado Watch in Effect as Second Round of ‘Significant' Storms Approaches Chicago Area  NBC Chicago
4. WATCH LIVE: Severe weather coverage from KCRG-TV9  KCRG
5. First Alert Weather: Another round of storms possible east of I-35 this afternoon  CBS TEXAS

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Tornado Watch, Severe Thunderstorm Warnings Issued as ‘Significant' Storms Move Through - NBC Chicago

1. Tornado Watch, Severe Thunderstorm Warnings Issued as ‘Significant' Storms Move Through  NBC Chicago
2. WATCH LIVE: Severe weather coverage from KCRG-TV9  KCRG
3. Severe Weather Outbreak Likely Across Central US With Multiple Strong Tornadoes Expected  FOX Weather
4. Severe risk persists this afternoon, evening  WHOP
5. First Alert Weather: Another round of storms possible east of I-35 this afternoon  CBS TEXAS
6. View Full Coverage on Google News

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March 31, 2023 at 11:19PM Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement - 03/07/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement and meeting materials.

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"High risk" weather outbreak with violent tornadoes hammers central U.S. - Axios

1. "High risk" weather outbreak with violent tornadoes hammers central U.S.  Axios
2. 'Particularly Dangerous Situation' Tornado Watch Expands As Far South As Texas  FOX Weather
3. 65 million people at risk from 'explosive thunderstorms'; gusts up to 70 mph in some areas: Friday weather  Yahoo! Voices
4. WATCH: Tornado rips through Little Rock area  FOX13 Memphis
5. Nearly 9M Americans hit with severe storm warning after deadly tornadoes last week  Daily Mail
6. View Full Coverage on Google News

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March 31, 2023 at 10:08PM Coronavirus (COVID-19) | CBER-Regulated Biologics

This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.

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Rare 'high risk' severe weather warning near Memphis; Iowa, Illinois - USA TODAY

1. Rare 'high risk' severe weather warning near Memphis; Iowa, Illinois  USA TODAY
2. Rare 'high risk' storm alert issued for parts of Midwest and Mid-South including potential for violent, long-track tornadoes  CNN
3. Severe Weather Outbreak Could Produce Long-Lived, Strong Tornadoes, Destructive Winds On Friday  FOX Weather
4. 65 million people at risk from 'explosive thunderstorms'; gusts up to 70 mph in some areas: Friday weather  Yahoo! Voices
5. Dangerous Storms and Tornadoes Are Expected in Midwest and South  The New York Times
6. View Full Coverage on Google News

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Numerous, Potentially Severe Storms Threaten Chicago Area; Tornadoes, Hail, Lightning All Possible - NBC Chicago

1. Numerous, Potentially Severe Storms Threaten Chicago Area; Tornadoes, Hail, Lightning All Possible  NBC Chicago
2. Severe storms will roar across the state today  KCCI Des Moines
3. Severe Weather Outbreak Likely Across Central US With Multiple Strong Tornadoes Expected  FOX Weather
4. Severe weather remains possible for Friday  ktlo.com
5. Iowa Weather Update: Strong to severe storms likely on Friday  We Are Iowa Local 5 News
6. View Full Coverage on Google News

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Severe Weather Outbreak Likely Across Central US With Multiple Strong Tornadoes Expected - FOX Weather

1. Severe Weather Outbreak Likely Across Central US With Multiple Strong Tornadoes Expected  FOX Weather
2. Severe storms will roar across the state today  KCCI Des Moines
3. Severe weather remains possible for Friday  ktlo.com
4. Severe Storms May Produce Long-Track Tornadoes, Damaging Winds, Large Hail Friday  FOX Weather
5. First Alert Forecast: Beautiful Thursday, Then Stormy Friday Night  WSMV 4
6. View Full Coverage on Google News

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March 31, 2023 at 03:53PM National Minority Health Month: Better Health Through Better Understanding

As the FDA observes National Minority Health Month this April, we are highlighting the Enhance Equity Initiative and our work to raise awareness on the importance of improving the health of racial and ethnic minority populations and reducing health disparities.

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March 30, 2023 at 08:23PM Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The purpose of this guidance is to provide a framework for considering whether and what type of 59 long-term neurologic, sensory and developmental evaluations could be useful to support a 60 determination of safety of a drug, biological product, or device.

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March 30, 2023 at 02:49PM Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions

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March 29, 2023 at 09:41PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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March 29, 2023 at 09:05PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine

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March 29, 2023 at 08:40PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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March 29, 2023 at 05:55PM Devices Guidances

This page lists Medical Device Guidance documents.

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March 28, 2023 at 10:54PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

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March 28, 2023 at 08:54PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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March 27, 2023 at 04:27PM 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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South reels from deadly tornado outbreak as new storm takes aim in the West - ABC News

1. South reels from deadly tornado outbreak as new storm takes aim in the West  ABC News
2. 25 dead after violent tornado in Mississippi, Georgia gov. to tour storm damage | LiveNOW from FOX  LiveNOW from FOX
3. News Wrap: Recovery underway after destructive Mississippi tornado  PBS NewsHour
4. School surveillance cameras capture moment tornado struck in Amory  WAPT Jackson
5. 30 million Southerners are at risk of dangerous weather Sunday -- just after tornadoes and storms killed 26 people  CNN
6. View Full Coverage on Google News

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March 24, 2023 at 07:58PM Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

This policy allows certain modifications to the design and manufacturing of previously approved PMA and HDE devices during the COVID-19 pandemic.

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March 24, 2023 at 05:07PM Blood Products Advisory Committee April 26, 2023 Meeting Announcement - 04/26/2023

This is the main page for the Blood Products Advisory Committee April 26, 2023 Meeting Announcement and meeting materials.

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March 24, 2023 at 02:08PM FAQs: What happens to EUAs when a public health emergency ends?

Answers to frequently asked questions about what happens to Emergency Use Authorizations (EUAs), and medical products available under EUA, when a public health emergency ends.

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Recalled eyedrops linked to deadly bacteria outbreak: What we know - USA TODAY

1. Recalled eyedrops linked to deadly bacteria outbreak: What we know  USA TODAY
2. Amarillo optometrists, eye care specialists warn against recalled eyedrops  KFDA
3. More than 10 different brands of eye drops recalled over contamination  ABC News
4. CDC: Recalled eyedrops linked to life-threatening infections  KOB 4
5. Outbreak linked to eyedrops leaves 68 infected, 8 blind and 3 dead, CDC says  WAVY TV 10
6. View Full Coverage on Google News

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Drug-resistant bacteria linked to recalled eye drops costs fire captain sight in one eye - CBS News

1. Drug-resistant bacteria linked to recalled eye drops costs fire captain sight in one eye  CBS News
2. More than 10 different brands of eye drops recalled over contamination  ABC News
3. CDC: Recalled eyedrops linked to life-threatening infections  KOB 4
4. Recalled eyedrops linked to deadly bacteria outbreak: What we know  USA TODAY
5. Amarillo optometrists, eye care specialists warn against recalled eyedrops  KFDA
6. View Full Coverage on Google News

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March 23, 2023 at 09:06PM Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - 04/27/2023

Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

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March 23, 2023 at 07:05PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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March 23, 2023 at 02:10PM Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

This revised guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.

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March 22, 2023 at 08:07PM Development & Approval Process (CBER)

Key resources and information related to CBER development & approval process.

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March 22, 2023 at 06:36PM Moderna COVID-19 Vaccines

Information about Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

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Death toll linked to contaminated eye drops rising as more report vision loss - ABC News

1. Death toll linked to contaminated eye drops rising as more report vision loss  ABC News
2. Two additional deaths linked to bacteria in recalled eye drops, CDC says  CNN
3. Recalled eyedrops are linked to Pseudomonas aeruginosa infections, CDC says  NPR
4. More deaths, injuries linked to recalled eyedrops  KTLA Los Angeles
5. Death toll climbs in outbreak linked to recalled eye drops  WPXI Pittsburgh
6. View Full Coverage on Google News

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March 22, 2023 at 05:40PM Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement - 02/28/2023

This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials.

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March 22, 2023 at 02:12PM 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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March 21, 2023 at 05:10PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

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March 20, 2023 at 01:25PM Cellular & Gene Therapy Products

CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

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March 20, 2023 at 03:20PM Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

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Frozen Fruit Recalled at Costco and Trader Joe's Stores Due to Risk of Hepatitis A Outbreak - Yahoo Life

1. Frozen Fruit Recalled at Costco and Trader Joe's Stores Due to Risk of Hepatitis A Outbreak  Yahoo Life
2. Frozen strawberries sold at Costco, Trader Joe's, recalled after hepatitis A outbreak  NPR
3. Frozen Strawberries Sold at Costco and Trader Joe’s Recalled Over Hepatitis A Risk  The New York Times
4. RECALL ALERT: Frozen fruit recalled at Costco, Trader Joe's due to risk of hepatitis A contamination  WFAA
5. 5 hepatitis A outbreaks in WA state linked to frozen organic strawberries says CDC  KIRO Seattle
6. View Full Coverage on Google News

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FDA recalls frozen organic strawberries sold at Trader Joe's and Costco - New York Post

1. FDA recalls frozen organic strawberries sold at Trader Joe's and Costco  New York Post
2. Frozen strawberries sold at Costco, Trader Joe's, recalled after hepatitis A outbreak  NPR
3. Frozen Strawberries Sold at Costco and Trader Joe’s Recalled Over Hepatitis A Risk  The New York Times
4. RECALL ALERT: Frozen fruit recalled at Costco, Trader Joe's due to risk of hepatitis A contamination  WFAA
5. Frozen strawberries sold Costco Trader Joes Aldi recalled HEPATITIS A infections in Washington state  Daily Mail
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Frozen organic strawberries recalled over possible link to hepatitis A outbreak - ABC News

1. Frozen organic strawberries recalled over possible link to hepatitis A outbreak  ABC News
2. Frozen strawberries sold at Costco, Trader Joe's, recalled after hepatitis A outbreak  NPR
3. Frozen Strawberries Sold at Costco and Trader Joe’s Recalled Over Hepatitis A Risk  The New York Times
4. Frozen fruit sold at Trader Joe's recalled due to Hepatitis A outbreak  CBS Boston
5. Frozen fruit recalled over risk of Hepatitis A contamination  Fox Business
6. View Full Coverage on Google News

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Frozen strawberries sold at Costco, Trader Joe's, recalled after hepatitis A outbreak - NPR

1. Frozen strawberries sold at Costco, Trader Joe's, recalled after hepatitis A outbreak  NPR
2. Frozen strawberries sold at Costco, Trader Joe's and Aldi recalled after hepatitis A infections  CNN
3. Frozen fruit sold at Trader Joe's recalled due to Hepatitis A outbreak  CBS Boston
4. Frozen fruit recalled over risk of Hepatitis A contamination  Fox Business
5. Strawberries recalled over possible health risk  YourErie

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March 17, 2023 at 04:18PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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March 17, 2023 at 02:04PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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March 17, 2023 at 03:30PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

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March 17, 2023 at 03:02PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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March 16, 2023 at 11:17AM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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March 16, 2023 at 04:33PM Antihemophilic Factor (Recombinant)

Lists contain the Antihemophilic Factor (Recombinant) products with supporting documents.

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March 16, 2023 at 02:59PM New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products

Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER). There are only a few ANDAs currently regulated at CBER, e.g., ANDAs related to blood transfusion products. Most ANDAs are reviewed by CDER.

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Jiang Yanyong, who exposed scope of SARS epidemic in 2003, dies at 91 - The Washington Post

1. Jiang Yanyong, who exposed scope of SARS epidemic in 2003, dies at 91  The Washington Post
2. Jiang Yanyong: Whistleblower doctor who exposed China's Sars cover-up dies  BBC
3. Chinese SARS whistleblower Jiang Yanyong dies at 91  NPR
4. Chinese doctor who blew the whistle on SARS dies at 91  WION
5. Chinese doctor who blew whistle on 2003 SARS outbreak dies  KGUN 9 Tucson News
6. View Full Coverage on Google News

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March 15, 2023 at 09:04PM Clinical Guidances

This page lists Clinical Guidance documents.

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March 15, 2023 at 05:18PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


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March 14, 2023 at 07:48PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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March 13, 2023 at 10:46PM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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March 13, 2023 at 10:24PM Investigational COVID-19 Convalescent Plasma

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.


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March 13, 2023 at 09:57PM Emergency Use Authorization for Vaccines to Prevent COVID-19

This is the Guidance for Industry for the Emergency Use Authorization for Vaccines to Prevent COVID-19. , COVID-19, Coronavirus Disease 2019, Vaccines , CBER, Biologics

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March 13, 2023 at 07:45PM Vivotif

For immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi.

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March 13, 2023 at 07:29PM VAXCHORA

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.

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March 13, 2023 at 03:05PM Moderna COVID-19 Vaccines

Information about Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

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March 10, 2023 at 07:51PM Cellular Therapy Products

Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.

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March 10, 2023 at 05:47PM Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research

The purpose of this guidance is to describe the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER’s managed review process. CBER, Biologics

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March 09, 2023 at 08:40PM TENIVAC

TENIVAC is a product approval Indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

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March 09, 2023 at 08:37PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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March 09, 2023 at 04:37PM Statistical Review and Evaluation - Fluarix

Statistical Review and Evaluation - Fluarix

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March 08, 2023 at 10:15PM SHINGRIX

This is the main page for the CBER SHINGRIX.

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Two more eyedrop brands recalled due to risks, FDA says - The Philadelphia Inquirer

1. Two more eyedrop brands recalled due to risks, FDA says  The Philadelphia Inquirer
2. FDA recalls two more eyedrop brands due to risks  CBS New York
3. FDA Recalls Two More Eye Drop Products After Emergency Recall In February  msnNOW
4. Deadly Drug-Resistant Bacteria Outbreak In IL Linked To Eyedrops: CDC  Patch.com
5. 2 more eyedrops recalled, FDA announces  AL.com
6. View Full Coverage on Google News

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March 08, 2023 at 07:02PM Consumer Updates

Science-based health and safety information you can trust.

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March 08, 2023 at 06:17PM Measles, Mumps and Rubella Virus Vaccine Live

Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II.

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Eyedrops recalled due to contamination risks that could lead to serious injury - NPR

1. Eyedrops recalled due to contamination risks that could lead to serious injury  NPR
2. FDA: Two more eyedrop brands recalled due to risks  WGN News
3. Eye Drops Recalled by Two Companies Over Safety Concerns  The Wall Street Journal
4. 2 more eyedrops recalled, FDA announces  AL.com
5. Deadly Drug-Resistant Bacteria Outbreak In IL Linked To Eyedrops: CDC  Patch
6. View Full Coverage on Google News

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March 08, 2023 at 01:16PM Gamunex-C, Gammaked

For use in primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy.

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March 07, 2023 at 06:29PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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March 07, 2023 at 04:17PM PROQUAD

The Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®), to include concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in children 15 months to 12 years of age if a second dose of measles, mumps, rubella, and varicella is needed, additional safety data after a first or second dose of ProQuad®, and to comply with the Physician’s Labeling Rule format.

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March 07, 2023 at 02:39PM 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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March 07, 2023 at 02:33PM Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

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March 07, 2023 at 02:19PM Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

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March 07, 2023 at 01:21PM Administrative Actions (Biologics)

This is the main page for the CBER Administrative Actions (Biologics).

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March 06, 2023 at 08:24PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

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March 06, 2023 at 05:19PM 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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March 06, 2023 at 03:54PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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March 06, 2023 at 12:54PM 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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Thousands without power in Kentucky, Tennessee, Michigan after storms - The Washington Post

1. Thousands without power in Kentucky, Tennessee, Michigan after storms  The Washington Post
2. Severe weather today: At least 13 dead as storms bring tornadoes and flooding to South, now sweeps across Northeast  WPVI-TV
3. Fierce Storms in South, Midwest Leave at Least 10 Dead  The Wall Street Journal
4. At least 5 dead following year's first severe spring weather outbreak  UPI News
5. Storms across the U.S. cause deaths and power outages  NPR
6. View Full Coverage on Google News

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Thousands without power in Kentucky, Tennessee, Michigan after storms - The Washington Post

1. Thousands without power in Kentucky, Tennessee, Michigan after storms  The Washington Post
2. At Least 12 Dead After Storms Sweep the South  The New York Times
3. At least 10 dead as storms lash the US, leaving millions without power  Daily Mail
4. At least 5 dead following year's first severe spring weather outbreak  UPI News
5. Fierce Storms in South and Midwest Leave at Least Nine Dead  The Wall Street Journal
6. View Full Coverage on Google News

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At least 12 dead after winter storm slams South, Midwest - CBS News

1. At least 12 dead after winter storm slams South, Midwest  CBS News
2. Thousands without power in Kentucky, Tennessee, Michigan after storms  The Washington Post
3. At least 5 dead following year's first severe spring weather outbreak  UPI News
4. At Least 12 Dead After Storms Sweep the South  The New York Times
5. Storms across the U.S. cause deaths and power outages  NPR
6. View Full Coverage on Google News

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March 03, 2023 at 11:55PM All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information

FDA determined that the risk of anaphylaxis following false negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies. Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in Prescribing Information.

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March 03, 2023 at 07:00PM FAQs: What happens to EUAs when a public health emergency ends?

Answers to frequently asked questions about what happens to Emergency Use Authorizations (EUAs), and medical products available under EUA, when a public health emergency ends.

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March 03, 2023 at 06:21PM Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement - 02/28/2023

This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials.

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March 03, 2023 at 03:07PM Clinical Trials: The Patient Experience - 04/13/2023

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a public virtual workshop on Thursday, April 13 from 11:00 a.m. – 3:00 p.m. ET.

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March 03, 2023 at 01:38PM Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement - 03/07/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement and meeting materials.

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March 02, 2023 at 09:12PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

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March 02, 2023 at 08:19PM Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

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March 02, 2023 at 07:29PM Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

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March 02, 2023 at 07:19PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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March 02, 2023 at 03:31AM Fluarix Quadrivalent

For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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March 02, 2023 at 02:24PM 2023 Meeting Materials, Blood Products Advisory Committee

This is the main page for the CBER 2023 Meeting Materials, Blood Products Advisory Committee.

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March 01, 2023 at 11:28PM VARIVAX (refrigerated and frozen formulations)

Product approval information for Varicella Virus Vaccine Live also known as Varivax.

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March 01, 2023 at 09:59PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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February 27, 2023 at 08:00PM 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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