January 31, 2023 at 08:17PM Industry (Biologics)

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

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Antony Blinken to meet Palestinian leaders amid round of deadly attacks - The Guardian

1. Antony Blinken to meet Palestinian leaders amid round of deadly attacks  The Guardian
2. Blinken, Israel's Benjamin Netanyahu meet amid outbreak of violence in the region  CBS News
3. Sec. Blinken had a plan for his visit to Jerusalem. Then he had to pivot  NPR
4. US foreign minister pleas for two-state solution on Israel visit | DW News  DW News
5. Abbas assures US security ties with Israel only partially cut, can be restored  The Times of Israel
6. View Full Coverage on Google News

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As Netanyahu talks Iran, Blinken makes US concerns over judicial shakeup clear - The Times of Israel

1. As Netanyahu talks Iran, Blinken makes US concerns over judicial shakeup clear  The Times of Israel
2. Blinken, Israel's Benjamin Netanyahu meet amid outbreak of violence in the region  CBS News
3. Sec. Blinken had a plan for his visit to Jerusalem. Then he had to pivot  NPR
4. Antony Blinken in Jerusalem: Urgent steps needed for calm  BBC
5. Blinken in Israel affirms support for Palestinian statehood  Reuters
6. View Full Coverage on Google News

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Sec. Blinken had a plan for his visit to Jerusalem. Then he had to pivot - NPR

1. Sec. Blinken had a plan for his visit to Jerusalem. Then he had to pivot  NPR
2. Blinken, Israel's Benjamin Netanyahu meet amid outbreak of violence in the region  CBS News
3. Antony Blinken in Jerusalem: Urgent steps needed for calm  BBC
4. Blinken in Israel affirms support for Palestinian statehood  Reuters
5. Blinken visit reaches new urgency as Israeli, Palestinian tensions boil  CNN

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Antony Blinken in Jerusalem: Urgent steps needed for calm - BBC

1. Antony Blinken in Jerusalem: Urgent steps needed for calm  BBC
2. Blinken, Israel's Benjamin Netanyahu meet amid outbreak of violence in the region  CBS News
3. Blinken visit reaches new urgency as Israeli, Palestinian tensions boil  CNN
4. Sec. Blinken had a plan for his visit to Israel. Then he had to pivot  NPR
5. Blinken urges calm, reaffirms ‘ironclad’ US support for Israel  Al Jazeera English

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January 30, 2023 at 10:11PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023

This is the list of guidance topics CBER is considering for development during Calendar Year 2023

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January 30, 2023 at 07:43PM Biological Approvals by Year

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

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January 27, 2023 at 06:42PM Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal

For further manufacturing use in the production of Anti-C3d AHG Blood Grouping Reagent under a Shared Manufacturing Agreement with Diagnostic Grifols, S.A.

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January 23, 2023 at 01:28PM ODACTRA

Product approval information for use in adults 18 through 65 years of age as immunotherapy for house dust mite- (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts.

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January 27, 2023 at 04:14PM Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Questions and Answers

Questions and answers for potential blood donors and blood recipients are provided. FDA revised its blood donor deferral recommendations for men who have had sex with other men (MSM) as well as those who have hemophilia or related clotting disorders.

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January 27, 2023 at 03:39PM Have You Given Blood Lately?

FDA works to ensure the safety of the more than 14 million units of blood and blood components donated in the U.S. each year. Learn how FDA helps safeguard the blood supply and how you can donate blood.

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January 27, 2023 at 02:49PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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January 27, 2023 at 02:49PM Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

This is the Draft Guidance for Industry Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

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January 25, 2023 at 09:49PM Multilingual COVID-19 Resources

The U.S. Centers for Disease Control and Prevention (CDC), and international and U.S. Government partners including FDA, are addressing an outbreak of coronavirus disease 2019 (COVID-19).

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January 25, 2023 at 09:43PM DENGVAXIA

DENGVAXIA For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratoryconfirmed previous dengue infection and living in endemic areas.

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January 25, 2023 at 06:40PM Temporada de huracanes: Prepárese

Es importante preparar las provisiones de emergencia y mantener a salvo los alimentos, el agua y los medicamentos antes, durante y después de cualquier cambio climático severo.

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January 25, 2023 at 12:45PM Coral Snake Antivenom

Coral Snake Antivenom product was manufactured by Wyeth Pharmaceuticals, now a wholly owned subsidiary of Pfizer, Inc. FDA has extended the expiration date on this lot of Antivenin (Micrurus fulvius) (Equine Origin), from January 31, 2018, to January 31, 2019. The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year.

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January 24, 2023 at 03:07PM 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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January 23, 2023 at 06:58PM 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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January 23, 2023 at 01:29PM Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.

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January 20, 2023 at 10:04PM 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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January 20, 2023 at 08:05PM 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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January 20, 2023 at 05:44PM 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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China plays down COVID outbreak with holiday rush at full tilt - Reuters

1. China plays down COVID outbreak with holiday rush at full tilt  Reuters
2. Covid Catastrophe Looms for China's New Year Travelers  Bloomberg
3. Lunar New Year tourism hopes fizzle as Chinese stay home  The Associated Press - en Español
4. For Chinese Lunar New Year tourists, retailers roll out rabbit dances, red lanterns  Reuters
5. China braces for another COVID wave, as first Lunar New Year without restrictions approaches  ABC News
6. View Full Coverage on Google News

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January 19, 2023 at 10:00PM Administrative Guidances

This page lists Administrative Guidance documents.

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January 19, 2023 at 08:56PM Remarks by Commissioner Robert M. Califf, M.D. at the FDA-U.S. Patent and Trademark Office Public Workshop - 01/19/2023

Remarks by Commissioner Robert M. Califf,
FDA-U.S. Patent and Trademark Office Public Workshop
Jan. 19, 2023
Washington, DC

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January 19, 2023 at 07:46PM 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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January 19, 2023 at 05:29PM Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

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January 19, 2023 at 01:32PM 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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January 18, 2023 at 09:53PM Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated Products

List including applications in alphabetical order by product name for which have approval documents available, and reflects the information as of the approval date.

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January 18, 2023 at 06:52PM 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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January 18, 2023 at 02:41PM 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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January 17, 2023 at 02:34PM Clinical Investigator Administrative Actions - Disqualification

Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Clinical Investigator Administative Actions - Disqualification

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January 17, 2023 at 08:38PM Drugs@FDA Data Files

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

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January 17, 2023 at 04:39PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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Shenzhen stocks lead gains in Asia-Pacific on cooled U.S. inflation outlook - CNBC

1. Shenzhen stocks lead gains in Asia-Pacific on cooled U.S. inflation outlook  CNBC
2. China's Dec home prices fall, more supportive policies likely  Reuters
3. Chinese home price slump shows no sign of abating as more cities record falls  South China Morning Post
4. China Home Prices Slump After Covid Outbreaks Stifle Rescue  Bloomberg
5. Decline in China's New Home Prices Stabilized in December  MarketWatch
6. View Full Coverage on Google News

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Shenzhen stocks lead gains in Asia-Pacific on cooled U.S. inflation outlook - CNBC

1. Shenzhen stocks lead gains in Asia-Pacific on cooled U.S. inflation outlook  CNBC
2. China's Dec home prices fall, more supportive policies likely  Reuters
3. China Home Prices Slump After Covid Outbreaks Stifle Rescue  Bloomberg
4. Chinese home price slump shows no sign of abating as more cities record falls  South China Morning Post
5. Decline in China's New Home Prices Stabilized in December  MarketWatch

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China Covid-19 Deaths: WHO, Coronavirus Data and Vaccines - Bloomberg

1. China Covid-19 Deaths: WHO, Coronavirus Data and Vaccines  Bloomberg
2. China reports nearly 60000 Covid deaths | Latest News | World News | English News | WION  WION
3. China says 60,000 people have died of Covid since early December  CNN
4. WHO urges China to release more information about new COVID infections  The Hill
5. WHO calls on China to release more data on Covid-19 outbreak  Financial Times
6. View Full Coverage on Google News

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China reports 60000 COVID-related deaths, says peak passed - The Associated Press

1. China reports 60000 COVID-related deaths, says peak passed  The Associated Press
2. China reports nearly 60000 Covid deaths | Latest News | World News | English News | WION  WION
3. China says 60,000 people have died of Covid since early December  CNN
4. WHO calls on China to release more data on Covid-19 outbreak  Financial Times
5. China: Country reports around 60000 Covid deaths, claims peak is over | Latest World News | WION  WION
6. View Full Coverage on Google News

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China reports 60000 COVID-related deaths, says peak passed - The Associated Press

1. China reports 60000 COVID-related deaths, says peak passed  The Associated Press
2. China reports nearly 60000 Covid deaths | Latest News | World News | English News | WION  WION
3. China says 60,000 people have died of Covid since early December  CNN
4. China coronavirus: 60,000 Covid-related deaths in just over a month  BBC
5. WHO calls on China to release more data on Covid-19 outbreak  Financial Times

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China sharply revises death toll linked to covid outbreak to 60000 from 37 - The Washington Post

1. China sharply revises death toll linked to covid outbreak to 60000 from 37  The Washington Post
2. China says 60,000 people have died of Covid since early December  CNN
3. China: Country reports around 60000 Covid deaths, claims peak is over | Latest World News | WION  WION
4. China reports 60,000 coronavirus-related deaths from December after concerns of underreporting  Fox News
5. China coronavirus: 60,000 Covid-related deaths in just over a month  BBC
6. View Full Coverage on Google News

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China sharply revises death toll linked to covid outbreak to 60000 from 37 - The Washington Post

1. China sharply revises death toll linked to covid outbreak to 60000 from 37  The Washington Post
2. China: Country reports around 60000 Covid deaths, claims peak is over | Latest World News | WION  WION
3. China says 60,000 people have died of Covid since early December  CNN
4. China reports nearly 60000 Covid-related deaths in a month • FRANCE 24 English  FRANCE 24 English
5. China coronavirus: 60,000 Covid-related deaths in just over a month  BBC

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China reports almost 60000 Covid-related deaths in a month - Financial Times

1. China reports almost 60000 Covid-related deaths in a month  Financial Times
2. Nearly 60,000 people have died of Covid in China in past five weeks  The Guardian
3. China sharply revises death toll linked to covid outbreak to 60000 from 37  The Washington Post
4. China reports huge rise in COVID-related deaths after data criticism  Reuters
5. China reports almost 60,000 COVID-related deaths in past month  Al Jazeera English
6. View Full Coverage on Google News

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January 12, 2023 at 04:47PM ADSTILADRIN

For the treatment of High-grade, Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer.

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January 11, 2023 at 09:09PM 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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January 11, 2023 at 07:39PM Tissue Reference Group

This update includes recommendations for FY 2015 for the Tissue Reference Group.

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January 11, 2023 at 05:57PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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January 11, 2023 at 05:21PM Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.

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January 10, 2023 at 11:07PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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January 10, 2023 at 09:49PM Regenerative Medicine Advanced Therapy Designation

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

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January 09, 2023 at 10:50PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

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January 09, 2023 at 08:43PM 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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January 09, 2023 at 04:55PM 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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January 06, 2023 at 05:26PM Consumer Updates

Science-based health and safety information you can trust.

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Can international tourists visit China? Everything you need to know about the country's reopening - CNN

1. Can international tourists visit China? Everything you need to know about the country's reopening  CNN
2. China 'under-representing' severity of COVID outbreak, says WHO  Al Jazeera English
3. As COVID surges in China, US begins testing more travelers  Yahoo News
4. China COVID flight testing makes no sense  The Hill
5. Travel curbs rack up as COVID-hit China readies reopening  Reuters
6. View Full Coverage on Google News

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China 'under-representing' true impact of Covid outbreak, WHO says - CNN

1. China 'under-representing' true impact of Covid outbreak, WHO says  CNN
2. WHO: China COVID Data Doesn't Show 'True Impact' | China Covid Latest News | English News LIVE  CNN-News18
3. Beds run out at Beijing hospital as COVID-19 spreads  The Associated Press - en Español
4. China's Covid Surge Will Test the US and Its Allies  Bloomberg
5. China calls on WHO to take "just" position on COVID-19  CNA

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January 05, 2023 at 08:21PM ROTARIX

Rotarix approval page indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.

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January 05, 2023 at 06:57PM Have You Given Blood Lately?

FDA works to ensure the safety of the more than 14 million units of blood and blood components donated in the U.S. each year. Learn how FDA helps safeguard the blood supply and how you can donate blood.

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Beds run out at Beijing hospital as COVID-19 spreads - The Associated Press - en Español

1. Beds run out at Beijing hospital as COVID-19 spreads  The Associated Press - en Español
2. Overwhelmed funeral home in China gives families 10 minutes to mourn  Insider
3. WHO concerned about risk to life in China, asks for reliable data on hospitalisations, deaths | WION  WION
4. China 'under-representing' true impact of Covid outbreak, says WHO  CNN
5. WHO says China releases COVID hospital data after reporting gap  Reuters
6. View Full Coverage on Google News

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China 'under-representing' true impact of Covid outbreak, says WHO - CNN

1. China 'under-representing' true impact of Covid outbreak, says WHO  CNN
2. Overwhelmed funeral home in China gives families 10 minutes to mourn  Insider
3. WHO concerned about risk to life in China, asks for reliable data on hospitalisations, deaths | WION  WION
4. China is now the centre of Covid. The world should be watching – and testing  The Guardian
5. China Covid: WHO warns about under-representing Covid deaths  BBC
6. View Full Coverage on Google News

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January 04, 2023 at 09:53PM Administrative Guidances

This page lists Administrative Guidance documents.

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January 04, 2023 at 08:12PM 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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January 04, 2023 at 07:07PM 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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China pledges 'final victory' over COVID as outbreak raises global alarm - Reuters

1. China pledges 'final victory' over COVID as outbreak raises global alarm  Reuters
2. COVID-19: Chinese state media plays down severity of virus  CNA
3. China Covid Outbreak Overwhelms Crematoriums With Bodies Seen Piling Up  Bloomberg
4. WHO advisers call for 'realistic' Chinese COVID data  Reuters
5. China pledges 'final victory' over COVID as outbreak raises global alarm  Yahoo News
6. View Full Coverage on Google News

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January 03, 2023 at 05:03PM 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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China blasts ‘unacceptable’ COVID curbs on travellers | Coronavirus pandemic News - Al Jazeera English

1. China blasts ‘unacceptable’ COVID curbs on travellers | Coronavirus pandemic News  Al Jazeera English
2. Beijing threatens response to 'unacceptable' virus measures  Yahoo News
3. China criticises 'unacceptable' new Covid rules for passengers flying in from territory  euronews
4. Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak  Fox News
5. Growing list of countries imposing COVID rules on China arrivals  Al Jazeera English

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China Covid Outbreak Overwhelms Crematoriums With Bodies Seen Piling Up - Bloomberg

1. China Covid Outbreak Overwhelms Crematoriums With Bodies Seen Piling Up  Bloomberg
2. COVID-19: Chinese state media plays down severity of virus  CNA
3. China media plays down COVID severity as WHO seeks detail on variants  Reuters
4. China downplays covid surge, stops publishing real-time covid-data I Latest World News I WION  WION
5. Why China's Latest Covid Wave Has Sparked Global Panic  NDTV
6. View Full Coverage on Google News

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Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak - Fox News

Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak  Fox NewsView Full Coverage on Google News

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Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak - Fox News

Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak  Fox NewsView Full Coverage on Google News

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Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak - Fox News

Chinese travelers facing COVID-19 testing requirements from more countries amid outbreak  Fox NewsView Full Coverage on Google News

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China's home prices fell at an accelerating rate in December, survey shows - CNBC

1. China's home prices fell at an accelerating rate in December, survey shows  CNBC
2. Chinese manufacturing weakens amid COVID-19 outbreak  NPR
3. China's manufacturing activity drops despite lifted COVID restrictions  Japan Today
4. China Home Sales Slump Persists in December Amid Covid Surge  Bloomberg
5. China’s reopening isn’t boosting economic activity—quite the reverse  Fortune
6. View Full Coverage on Google News

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