April 29, 2022 at 11:07PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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April 29, 2022 at 10:26PM Procleix HIV-1/HCV Assay

Product approval information is indicated for the qualitative detection of human immunodeficiency virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion.

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April 29, 2022 at 10:20PM ORTHO T. cruzi ELISA Test System

Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating.

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April 29, 2022 at 10:18PM Ortho HCV Version 3.0 ELISA Test System

Product approval information for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood.

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April 29, 2022 at 10:15PM NGI UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV

The intended use of the National Genetics Institute’s (NGI) UltraQual® Multiplex PCR Assay is to screen source plasma for HCV, HIV-1, HIV-2 and HBV. A maximum number of 512 aliquots from individual donations will be pooled using Tecan Evo robotic pipetting devices. The pools will then be tested using the multiplex assay to detect the presence of hepatitis C virus, human immunodeficiency virus types 1 and 2, and hepatitis B virus. Any pooled samples that test positive for any of these viruses will then be retested, per NGI’s resolution algorithm, to identify the individual positive donation. The assay will discriminate between HCV, HIV-1, HIV-2 and HBV, but will not discriminate between HIV-1 Group M and Group O viruses.

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April 29, 2022 at 05:36PM Genetic Systems HBsAg EIA 3.0

Product approval information is indicated for detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma, and also in cadaveric serum specimens.

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April 29, 2022 at 05:10PM 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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April 29, 2022 at 05:04PM 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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'Entry only. No exit:' Beijing sees more COVID closures as anger grows in Shanghai - Reuters

1. 'Entry only. No exit:' Beijing sees more COVID closures as anger grows in Shanghai  Reuters
2. Why does China still have a zero-Covid lockdown strategy? - BBC News  BBC News
3. Political stakes high as Beijing responds to virus outbreak  The Associated Press
4. 180 million people impacted by China's Covid lockdowns. Here's what you need to know  CNN
5. Beijing classes go online as COVID-19 restrictions tighten  Fox News

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'Entry only. No exit:' Beijing sees more COVID closures as anger grows in Shanghai - Reuters

1. 'Entry only. No exit:' Beijing sees more COVID closures as anger grows in Shanghai  Reuters
2. Why does China still have a zero-Covid lockdown strategy? - BBC News  BBC News
3. Shanghai Covid Cases Rise For First Time in Six Days  Bloomberg
4. Beijing classes go online as COVID-19 restrictions tighten  Fox News
5. Political stakes high as Beijing responds to virus outbreak  The Washington Post
6. View Full Coverage on Google News

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April 28, 2022 at 09:06PM Premarket Notification Submissions for Blood and Plasma Warmers

Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers, CBER, biologics, guidance, reviewer, premarket, PMA, blood, plasma, warmer

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April 28, 2022 at 08:54PM Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components

Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components, CBER, biologics, guidance, reviewers, blood, container, collection, processing

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April 28, 2022 at 06:19PM COBAS TaqScreen West Nile Virus Test

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating.

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April 28, 2022 at 06:11PM COBAS TaqScreen MPX Test

Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay

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April 28, 2022 at 06:04PM COBAS AmpliScreen HIV-1 Test

Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion

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April 28, 2022 at 06:01PM COBAS AmpliScreen HCV Test

Product approval information for detecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV.

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April 28, 2022 at 05:57PM COBAS AmpliScreen HBV Test

Product approval information is indicated for:
• Qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma
• Testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)

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April 28, 2022 at 05:48PM Cambridge Biotech HIV-1 Western Blot Kit

Product approval information for urine specimen testing

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April 27, 2022 at 04:58PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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April 25, 2022 at 10:21PM 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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China's capital in race to detect COVID cases, avoid Shanghai's distress - Reuters

1. China's capital in race to detect COVID cases, avoid Shanghai's distress  Reuters
2. Authorities to test 20 million people for COVID-19 amid outbreak in Beijing  CBS News
3. Shanghai seeks 'societal zero COVID' with rounds of testing  The Associated Press
4. China grapples with political challenges as Covid death toll mounts  CNN
5. Coronavirus Daily: Fear of What Lies Ahead for Beijing  Bloomberg
6. View Full Coverage on Google News

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Oil settles up, rebounds on China's plans to support economy - Reuters

1. Oil settles up, rebounds on China's plans to support economy  Reuters
2. Oil prices rebound from sharp drop on China demand concerns  CNBC
3. Uncertainty Leaves Oil Prices Stuck At $100  OilPrice.com
4. Oil Steadies as Traders Weigh Ukraine Fallout, China's Outbreak  Bloomberg
5. Oil extends gains on Russia-Europe tension, China stimulus hopes  Reuters
6. View Full Coverage on Google News

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April 22, 2022 at 08:42PM NovoSeven

Product approval information is indicated for treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.

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April 26, 2022 at 07:33PM Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card

Manufacture of a "Monoclonal Rh Phenotype Card"

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Beijing expands mass testing as lockdown fears grow - Yahoo News

1. Beijing expands mass testing as lockdown fears grow  Yahoo News
2. Covid Outbreak in Beijing Prompts Order for Nearly Citywide Testing  The New York Times
3. Mass COVID testing prompts panic buying in Beijing - News  Reuters
4. Beijing locks down some areas as COVID-19 cases mount  WHIO
5. Beijing Residents Stockpile Food, Supplies As Lockdown Fears Grow  NBC News

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Treasury yields dip, with focus on Covid outbreak in China and fears of economic slowdown - CNBC

1. Treasury yields dip, with focus on Covid outbreak in China and fears of economic slowdown  CNBC
2. FTSE crashes more than 2% in early trades on fears about Covid lockdowns in Shanghai  Proactive
3. Chinese Markets Tank as Investors Worry About Covid-19 Lockdowns  The Wall Street Journal
4. Mainland Chinese shares tumble amid Covid fears as Beijing expands testing; HSBC profit falls  CNBC
5. Fears of Yet More Inflation Hound Markets as China Tackles Covid  Bloomberg
6. View Full Coverage on Google News

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Beijing tests 20 million residents amid 'fast and furious' Omicron outbreak - CNN

1. Beijing tests 20 million residents amid 'fast and furious' Omicron outbreak  CNN
2. Covid Live Updates: Testing, Lockdowns, and More News  The New York Times
3. Mass COVID testing prompts panic buying in Beijing - News  Reuters
4. Most of Beijing to be tested for Covid amid lockdown fears  POLITICO
5. Beijing Residents Stockpile Food, Supplies As Lockdown Fears Grow  NBC News

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Beijing will mass-test most of the city as COVID-19 cases mount - NPR

1. Beijing will mass-test most of the city as COVID-19 cases mount  NPR
2. Beijing kicks off mass testing after spike in Covid cases  BBC
3. Mass COVID testing prompts panic buying in Beijing - News  Reuters
4. Beijing Orders Citywide Covid-19 Testing as Fears of Lockdown Spark Panic-Buying  The Wall Street Journal
5. China racing to curb COVID outbreak  Al Jazeera English
6. View Full Coverage on Google News

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April 25, 2022 at 04:37PM Auszyme Monoclonal

Product approval information is indicated for use to include cadaveric serum specimen testing.

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April 25, 2022 at 04:07PM Anti-B (Murine Monoclonal)

Product information for Anti-B (Murine Monoclonal)

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Panic buying in Beijing as district starts mass COVID testing - Reuters

1. Panic buying in Beijing as district starts mass COVID testing  Reuters
2. China: Beijing begins mass COVID testing after spike in cases  Al Jazeera English
3. Beijing districts placed under lockdown as COVID cases mount  The Associated Press
4. Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNN
5. Beijing District Orders 3 Days of Covid Tests to Quash Outbreak  Bloomberg
6. View Full Coverage on Google News

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China's capital city warns of more Covid cases and begins mass testing in the central business district - CNBC

1. China's capital city warns of more Covid cases and begins mass testing in the central business district  CNBC
2. Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNN
3. Beijing shoppers clear store shelves as district starts mass testing  Reuters
4. Beijing District Orders 3 Days of Covid Tests to Quash Outbreak  Bloomberg
5. Beijing districts placed under lockdown as cases mount  The Associated Press

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China's capital city warns of more Covid cases and begins mass testing in the central business district - CNBC

1. China's capital city warns of more Covid cases and begins mass testing in the central business district  CNBC
2. Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNN
3. Beijing's biggest district begins COVID mass testing  Reuters
4. Shanghai erects metal barriers in fight against COVID-19  Fox News
5. Lockdown Jitters Hit Beijing as Shanghai Virus Deaths Climb  Bloomberg
6. View Full Coverage on Google News

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China's capital city warns of more Covid cases and begins mass testing in the central business district - CNBC

1. China's capital city warns of more Covid cases and begins mass testing in the central business district  CNBC
2. Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNN
3. Beijing's biggest district begins COVID mass testing  Reuters
4. China Races to Stop Beijing Outbreak as Shanghai Deaths Climb  Bloomberg
5. Shanghai erects metal barriers in fight against COVID-19  Fox News

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Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues - CNN

1. Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNN
2. China's capital city warns of more Covid cases and begins mass testing in the central business district  CNBC
3. Shanghai erects metal barriers in fight against COVID-19  Fox News
4. China Races to Stop Beijing Outbreak as Shanghai Deaths Climb  Bloomberg
5. Covid-19 Cases Jump in Beijing as New Deaths Triple in Shanghai  The Wall Street Journal
6. View Full Coverage on Google News

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Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues - CNN

Beijing races to contain 'urgent and grim' Covid outbreak as Shanghai lockdown continues  CNNView Full Coverage on Google News

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Shanghai fences up COVID-hit areas, fuelling fresh outcry - Reuters

1. Shanghai fences up COVID-hit areas, fuelling fresh outcry  Reuters
2. Frustration grows in Shanghai, China as harsh COVID lockdowns continue  New York Post
3. Shanghai erects metal barriers in fight against COVID-19  The Associated Press
4. Shanghai Reports Record Daily Covid Deaths in Current Outbreak  Bloomberg
5. Shanghai authorities fence off COVID-hit areas, sparking outrage  Al Jazeera English
6. View Full Coverage on Google News

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April 22, 2022 at 08:52PM ABBOTT HIVAB HIV-1/HIV-2 (rDNA) EIA

HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative
detection of antibodies to human immunodeficiency viruses type 1 and/or type 2
(HIV-1/HIV-2) in human serum, plasma, or cadaveric serum

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April 22, 2022 at 08:50PM ABBOTT HCV EIA 2.0

Product approval information is indicated for cadaveric serum specimen testing.

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April 22, 2022 at 08:45PM 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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April 22, 2022 at 08:42PM NovoSeven

Product approval information is indicated for treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.

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April 22, 2022 at 06:39PM FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022

The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 1-3 PM (EST) entitled “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology to identify areas of conceptual

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April 22, 2022 at 04:29PM 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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April 22, 2022 at 02:14PM 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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April 22, 2022 at 01:19PM Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates - 05/24/2022

New event page to promote CBER's annual patient engagement and regenerative medicine workshop. The webpage will include information about the event, including the agenda and event details. We would like the event to be featured here: https://ift.tt/MtVHwjX

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April 21, 2022 at 10:19PM Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

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April 21, 2022 at 08:17PM HIZENTRA

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

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April 20, 2022 at 10:13PM Refuse to Accept Policy for 510(k)s

This document explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission should be accepted for substantive review.

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April 20, 2022 at 07:44PM Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.

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April 19, 2022 at 09:36PM CANDIN

Submission Tracking Number (STN) BL 103257/5066 has been assigned to your recent supplement to your biologics license application for Candida albicans Skin Test Antigen for Cellular Hypersensitivity, CANDIN®, dated April 5, 2016. Your submission is in the form of a “Supplement – Changes Being Effected” as described under 21 CFR 601.12(c)(5).

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April 19, 2022 at 09:47PM 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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April 19, 2022 at 07:31PM 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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April 19, 2022 at 05:46PM Preguntas y respuestas sobre Comirnaty (Vacuna de ARNm contra el COVID-19)

La FDA llevó a cabo una evaluación exhaustiva de los datos y la información presentados en la Solicitud de Licencia Biológica (BLA, por sus siglas en inglés). para Comirnaty antes de tomar la determinación de que la vacuna es segura y eficaz para prevenir el COVID-19 en personas de 16 años y mayores

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April 18, 2022 at 09:13PM FDASIA Section 705 Annual Reports

Annual Reports published by requirement of FDASIA Section 705

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April 19, 2022 at 02:28PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

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April 18, 2022 at 09:09PM 2022 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main page for CBER 2022 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC).

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April 18, 2022 at 09:08PM Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting Announcement - 06/09/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting Announcement.

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April 18, 2022 at 09:06PM Devices Guidances

This page lists Medical Device Guidance documents.

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Shanghai reports first official Covid deaths in weeks-long lockdown - CNN

1. Shanghai reports first official Covid deaths in weeks-long lockdown  CNN
2. Shanghai Reports First COVID-19 Deaths Since Beginning of Lockdown  The Daily Beast
3. China reports first Covid deaths in Shanghai - BBC News  BBC News
4. Shanghai Reports First COVID-19 Deaths Of Latest Outbreak  NPR
5. Shanghai reports first COVID deaths amid sweeping lockdowns  The Hill
6. View Full Coverage on Google News

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Bird flu pushes egg prices up across the United States - The Washington Post

1. Bird flu pushes egg prices up across the United States  The Washington Post
2. Inflation causes increased egg prices in the U.S., but not yet in Tucson  KGUN9
3. Deadly Bird Flu Outbreak, Supply Chain Issues Cause Egg Prices To Soar  News On 6
4. Rising egg prices impacting Arkansas bakeries  THV11
5. Inflation, bird flu impact US bakeries ahead of Easter 2022  Fox Business
6. View Full Coverage on Google News

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Inflation, bird flu impact US bakeries ahead of Easter 2022 - Fox Business

1. Inflation, bird flu impact US bakeries ahead of Easter 2022  Fox Business
2. Bird flu pushes egg prices up across the United States  The Washington Post
3. Rising egg prices impacting Arkansas bakeries  THV11
4. Egg prices soar as the hunt is on for stocked shelves  KELOLAND.com
5. Deadly Bird Flu Outbreak, Supply Chain Issues Cause Egg Prices To Soar  News On 6
6. View Full Coverage on Google News

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April 15, 2022 at 10:40PM 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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April 15, 2022 at 01:53PM 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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New COVID omicron subvariants are spreading across New York. Here's what to know - USA TODAY

1. New COVID omicron subvariants are spreading across New York. Here's what to know  USA TODAY
2. Thursday morning COVID-19 update - April 14, 2022  WTHR
3. New York identifies 2 sub lineages of coronavirus omicron subvariant spreading through state  WABC-TV
4. Covid News: New Omicron Subvariants Spreading Fast in New York  The New York Times
5. CNY had first outbreak in US of new Covid strains: What we know and what we don’t  syracuse.com
6. View Full Coverage on Google News

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April 14, 2022 at 06:55PM Administrative Guidances

This page lists Administrative Guidance documents.

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April 13, 2022 at 08:13PM Vascular-Based Biomarkers For Evaluation of Biological Product Safety and Efficacy

The main focus of this research program is to study the mechanisms by which biological products or pathogens alter the functioning or integrity of the vascular system in both vascular endothelial cell culture systems and animal models.

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April 13, 2022 at 07:53PM Toward More Effective Treatment of Blood Clotting Disorders: Pharmacogenomic Studies of ADAMTS13 and Related Proteins

A description of Chava Kimchi-Sarfaty's research program and related publications.

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April 13, 2022 at 07:44PM Study of the regulation of blood coagulation by factors VIIa and IXa

A description of Mikhail Ovanesov's research program and related publications.

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April 13, 2022 at 03:37PM Clinical Guidances

This page lists Clinical Guidance documents.

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April 13, 2022 at 02:59PM Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability

The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic popu

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China accuses US of 'weaponizing' extended Shanghai lockdown - CNN

1. China accuses US of 'weaponizing' extended Shanghai lockdown  CNN
2. US orders all non-emergency government staff to leave Shanghai  New York Post
3. U.S. State Department orders non-essential consulate staff to leave Shanghai amid COVID outbreak  CBS News
4. State Department to Shanghai Staff: Leave Now  The Daily Beast
5. US warns against travel to China over ‘arbitrary’ enforcement of local laws, COVID-19 restrictions  Yahoo News

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Severe weather outbreak looms for Wednesday, tornadoes and damaging wind gusts possible - FOX 59 Indianapolis

1. Severe weather outbreak looms for Wednesday, tornadoes and damaging wind gusts possible  FOX 59 Indianapolis
2. Severe storm risk area expands in Iowa  KCCI Des Moines
3. Weather: Storms mainly west tonight, more possible Wednesday  WWLTV
4. Kane County Emergency Management Warns of Severe Weather Wednesday  kanecountyconnects.com
5. Strong storms to hit Arkansas Wednesday | Apr 12 Forecast  5NEWS
6. View Full Coverage on Google News

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Severe weather outbreak looms for Wednesday, tornadoes and damaging wind gusts possible - FOX 59 Indianapolis

1. Severe weather outbreak looms for Wednesday, tornadoes and damaging wind gusts possible  FOX 59 Indianapolis
2. Weather: Storms mainly west tonight, more possible Wednesday  WWLTV
3. Severe storm risk area expands in Iowa  KCCI Des Moines
4. Tornado Watch issued for most of Siouxland, including Sioux City, until 10 pm  KTIV Siouxland's News Channel
5. Tornadoes possible as Michigan may get first severe thunderstorms of season  MLive.com
6. View Full Coverage on Google News

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April 12, 2022 at 02:10PM 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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U.S. State Department orders all non-emergency government staff in Shanghai to leave as Covid surges - CNBC

1. U.S. State Department orders all non-emergency government staff in Shanghai to leave as Covid surges  CNBC
2. State Department orders staff to leave Shanghai, warns of 'arbitrary enforcement' of COVID-19 restrictions  Fox News
3. U.S. orders some personnel to leave Shanghai consulate  Reuters
4. US orders consular to leave Shanghai amid COVID outbreak  The Associated Press - en Español
5. Dr. Redfield: China's failed 'zero-COVID' policy proves lockdowns don't work  Fox News

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April 11, 2022 at 08:43PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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April 11, 2022 at 08:40PM Clinical Investigator Inspection List Q-S

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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April 11, 2022 at 08:38PM Clinical Investigator Inspection List T-Z

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

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April 11, 2022 at 07:17PM Vaccines Research

List of Vaccines Research.

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April 11, 2022 at 07:16PM Supporting the Production of Safe and Effective Influenza Vaccines

A description of Zhiping Ye's research program and related publications.

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April 11, 2022 at 06:02PM Development of Quantitative Assays to Evaluate the Safety of Cell Substrates and Vaccines

A description of Keith Peden's research program and related publications.

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April 11, 2022 at 04:58PM New Approaches to the Development and Evaluation of Vaccines Against Hepatitis Viruses

A description of Marian Major's research program and related publications.

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April 11, 2022 at 04:18PM Section 8500: Compliance

This is the SOPP Section 8500: Compliance main page.

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Guangzhou closes to most arrivals as China's outbreak grows - The Associated Press

Guangzhou closes to most arrivals as China's outbreak grows  The Associated PressView Full Coverage on Google News

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Shanghai hospital pays the price for China's COVID response - The Associated Press - en Español

1. Shanghai hospital pays the price for China's COVID response  The Associated Press - en Español
2. Shanghai’s Omicron Outbreak Corners Chinese Leader  The Wall Street Journal
3. Shanghai's high asymptomatic COVID rate could be due to including mild cases  Yahoo News
4. Shanghai to start easing lockdown after another mass testing  The Associated Press - en Español
5. Shanghai, Guangzhou Plan More Mass Tests as Covid Cases Rise  Bloomberg
6. View Full Coverage on Google News

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April 08, 2022 at 09:52PM Tissue Notices, Proposed and Final Rules

List of Tissue Notices, Proposed and Final Rules

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April 08, 2022 at 09:26PM Advanced Technology for Reducing the Risk of Transmission by Transfusion

OBRR performs regulatory evaluation of in vitro diagnostic devices used to screen for infectious microorganisms in blood donations.

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April 07, 2022 at 06:47PM 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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April 07, 2022 at 06:23PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

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April 07, 2022 at 04:05PM 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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April 07, 2022 at 04:02PM 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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April 07, 2022 at 03:00PM Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Pharmacology/Toxicology

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April 07, 2022 at 02:08PM 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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China's COVID lockdown policy is testing the limits of Shanghai : Goats and Soda - NPR

1. China's COVID lockdown policy is testing the limits of Shanghai : Goats and Soda  NPR
2. Shanghai’s ‘grim’ Covid outbreak threatens more global supply chain disruption  The Guardian
3. What you need to know about the coronavirus right now  Yahoo News
4. China’s COVID-19 outbreak: What’s happening in China?  Deseret News
5. In Shanghai, a long, fruitless wait for help amid COVID lockdown  Reuters
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After Gridiron Dinner, a covid outbreak among Washington A-list guests - The Washington Post

1. After Gridiron Dinner, a covid outbreak among Washington A-list guests  The Washington Post
2. Elite D.C. appears to be getting pummeled with Covid  POLITICO
3. Merrick Garland Is Latest Attendee Of D.C.’s A-List Gridiron Dinner To Test Positive For Covid  Deadline
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April 06, 2022 at 06:49PM Vaccine EUA Questions and Answers for Stakeholders

Questions and answers about vaccine Emergency Use Authorizations for stakeholders including industry, health care providers, pharmacists, and state, local, tribal, and territorial governments

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April 05, 2022 at 08:02PM 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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26 million people in Shanghai are locked down due to a surge in COVID cases - NPR

1. 26 million people in Shanghai are locked down due to a surge in COVID cases  NPR
2. Covid Cases in China Hit Record, as Shanghai Extends Lockdown  The Wall Street Journal
3. 'This is inhumane': the cost of zero Covid in Shanghai  The Guardian
4. COVID outbreak 'extremely grim' as Shanghai extends lockdown  ABC News
5. Shanghai extends COVID-19 lockdown, outbreak remains 'extremely grim'  Fox News
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China sends in military to help with Shanghai virus outbreak - ABC News

1. China sends in military to help with Shanghai virus outbreak  ABC News
2. Military sent to test Shanghai's 26 million residents  Reuters
3. China sends health workers, military to Shanghai to help curb COVID wave  New York Post
4. Drone footage shows deserted Shanghai as city of 26 million people remains in lockdown  Guardian News
5. Shanghai reports 13086 new asymptomatic, 268 new symptomatic coronavirus cases for April 4  Reuters.com
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April 04, 2022 at 10:25PM Section 8200: Investigational New Drugs (INDs)

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

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April 04, 2022 at 10:05PM Section 8100: Communication

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

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April 04, 2022 at 09:29PM Section 8000: General Information

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

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April 04, 2022 at 09:10PM Postmarketing Reports

Postmarketing Reports

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April 04, 2022 at 09:03PM OCTAGAM

Product approval information is indicated for the treatment of chronicimmune purpura (ITP) in adults

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Shanghai to extend lockdown of 26 million people as it reviews COVID test results - Reuters

1. Shanghai to extend lockdown of 26 million people as it reviews COVID test results  Reuters
2. China drafts in the military as Shanghai ordered to test 25 million residents for Covid  CNN
3. China sends in military to help with Shanghai virus outbreak  The Associated Press - en Español
4. Military sent to test Shanghai's 26 million residents  Reuters
5. China aids Shanghai COVID outbreak with military staff  WKRC TV Cincinnati
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April 04, 2022 at 02:51PM CINRYZE

Product approval information is indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

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April 01, 2022 at 07:10PM Vaccines Research

List of Vaccines Research.

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April 01, 2022 at 07:02PM Section 9150: Office of Tissues and Advanced Therapies

This is the SOPP Section 9150: Office of Tissues and Advanced Therapies.

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April 01, 2022 at 03:35PM Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement - 03/10/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement.

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April 01, 2022 at 02:57PM Give Your Community a Boost: Combatting Misinformation Through Communication and Research

During National Minority Health Month, we highlight the ways in which we are working to improve minority health and health equity.

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Here's how China's latest Covid lockdowns have affected American businesses in the country - CNBC

1. Here's how China's latest Covid lockdowns have affected American businesses in the country  CNBC
2. Shanghai Hospital Harbors Unreported Covid-19 Outbreak, Deaths  The Wall Street Journal
3. In China's 'zero-Covid' lockdowns, patients with other diseases are struggling to survive  CNN
4. Shanghai bankers and traders sleeping in offices amid Covid lockdown  Insider
5. As Shanghai expands COVID lockdown, life on hold in city of 26 million  Reuters
6. View Full Coverage on Google News

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