June 30, 2022 at 07:17PM Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

The reissued cybersecurity guidance will highlight secure device design and recommendations to address cybersecurity in premarket submissions.

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June 30, 2022 at 06:28PM Vaccines Research

List of Vaccines Research.

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June 30, 2022 at 04:49PM Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.

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June 30, 2022 at 04:21PM Update: COVID-19 Vaccine Booster Composition

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022 fall and winter seasons.

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June 30, 2022 at 04:16PM 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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June 30, 2022 at 06:18AM Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

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June 29, 2022 at 07:11PM 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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June 29, 2022 at 04:37PM Vaccines Protect Children From Harmful Infectious Diseases

If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes the routinely administered vaccines for children and provides answers to commonly asked questions.

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June 29, 2022 at 03:11PM 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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June 28, 2022 at 09:14PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

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June 28, 2022 at 06:46PM Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment

Guidance for Industry: Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment

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June 28, 2022 at 06:30PM Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment

Guidance for industry: Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment

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June 28, 2022 at 03:20PM Re-Gen Active Lab, Inc. - 620763 - 05/27/2022

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)


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June 28, 2022 at 02:44AM Blood Grouping Reagents - ORTHO Sera, ALBAclone

Product approval information is indicated for:
•ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).
•ORTHO Sera Anti-D (IAT) is for the in vitro detection of human Rh D positive red blood cells by the indirect antiglobulin test.
•ORTHO Sera Anti-Lea is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-Leb is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-N is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test.

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June 27, 2022 at 05:06PM Consumer Updates

Science-based health and safety information you can trust.

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Destruction everywhere, help scarce after Afghanistan quake - KSL.com

1. Destruction everywhere, help scarce after Afghanistan quake  KSL.com
2. After earthquake that killed 1,000, Afghanistan braces for cholera, disease outbreaks  CNN
3. ‘We jumped in the car as soon as we heard’: Afghans race to help amid wait for international aid  The Guardian
4. Death toll of children in Afghanistan quake rises to 155  The Washington Post
5. Afghan health official warns of disease outbreak among earthquake survivors  Reuters
6. View Full Coverage on Google News

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After earthquake that killed 1,000, Afghanistan braces for cholera, disease outbreaks - CNN

After earthquake that killed 1,000, Afghanistan braces for cholera, disease outbreaks  CNNView Full Coverage on Google News

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June 24, 2022 at 08:07PM OTAT Learn

Welcome to OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education.

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June 24, 2022 at 07:42PM 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/cONp1yu

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June 24, 2022 at 05:12PM MP Diagnostics HTLV Blot 2.4

Product approval information for detection of antibodies to HTLV-I (anti-HTLV-I) and/ or antibodies to HTLV-II (anti-HTLV-II) in human serum and plasma specimens.

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June 24, 2022 at 05:08PM Lot Distribution Database (LDD)

Lot Distribution Database (LDD)

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June 24, 2022 at 02:45PM Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Electronic Submissions

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'What do we do when another disaster hits?' Afghans face crises on all fronts after quake kills 1,000 - CNN

1. 'What do we do when another disaster hits?' Afghans face crises on all fronts after quake kills 1,000  CNN
2. Need for Aid Is Critical in Afghanistan After Devastating Earthquake  The New York Times
3. Afghanistan earthquake: Locals mourn the dead and search for shelter  The Washington Post
4. UN readies for possible cholera outbreak after Afghanistan earthquake  Reuters.com
5. Roanoke area refugees look to help those impacted by earthquake  WSLS 10
6. View Full Coverage on Google News

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June 23, 2022 at 02:00PM Meetings for Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy (BT) Designated Products

OTAT information about meetings for Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy (BT) Designated Products

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June 23, 2022 at 02:00PM OTAT Pre-BLA Meetings

OTAT Pre-BLA meeting information

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June 23, 2022 at 02:00PM OTAT Type C Meetings

OTAT Type C Meetings information

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June 23, 2022 at 02:00PM OTAT IND Milestone (Type B) Meetings

IND Milestone (Type B) Meeting Information

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June 23, 2022 at 02:00PM OTAT Type A Meetings

Information about OTAT Type A Meetings

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June 23, 2022 at 02:00PM OTAT Pre-IND Meetings

OTAT's Pre-IND meeting information

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June 23, 2022 at 02:00PM OTAT INTERACT Meeting

Information about OTAT's INTERACT Meetings

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June 23, 2022 at 02:00PM Interactions with Office of Tissues and Advanced Therapies

Office of Tissues and Advanced Therapies

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June 22, 2022 at 10:28PM Charter of the Blood Products Advisory Committee

This is the Charter of the Blood Products Advisory Committee.

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June 22, 2022 at 07:46PM FDA's Critical Role in Ensuring Supply of Influenza Vaccine

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines.

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June 22, 2022 at 03:49PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022

This is the list of guidance topics CBER is considering for development during Calendar Year 2022

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June 21, 2022 at 09:48PM General Biologics, Notices, Proposed and Final Rules

General Biologics, Notices, Proposed and Final Rules

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June 21, 2022 at 07:32PM 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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June 21, 2022 at 02:30PM Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement - 06/28/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement.

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June 17, 2022 at 08:31PM 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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June 16, 2022 at 04:12PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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June 17, 2022 at 06:26PM Vaccine Notices, Proposed and Final Rules

List of vaccine notices, proposed and final rules

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June 17, 2022 at 03:24PM 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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June 17, 2022 at 02:52PM Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

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North Korea reports another disease outbreak amid COVID-19 wave - Fox News

1. North Korea reports another disease outbreak amid COVID-19 wave  Fox News
2. North Korea battles outbreak of unidentified disease  Reuters
3. N.Korea sends aid to 800 families suffering from intestinal epidemic  Yahoo News
4. N. Korea reports another disease outbreak amid COVID-19 wave  ABC News
5. North Korea faces infectious disease outbreak amid COVID battle  Reuters

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June 16, 2022 at 09:27PM Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

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June 16, 2022 at 07:08PM Section 8200: Investigational New Drugs (INDs)

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

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June 16, 2022 at 03:07PM Industry Frequently Asked Questions

Frequently asked questions and the associated answers sorted by topic area

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June 14, 2022 at 04:40PM Tissue Notices, Proposed and Final Rules

List of Tissue Notices, Proposed and Final Rules

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June 15, 2022 at 08:19PM Procleix Ultrio Elite Assay

•Intended to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from individual human donors, including donors of whole blood, blood compo

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June 15, 2022 at 02:36PM Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

This is the Draft Guidance for Industry - Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

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June 14, 2022 at 06:20PM Tissue Guidances

This page contains a listing of tissue related guidances.

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June 14, 2022 at 09:29PM Workshop on the Regulation of HIV Test Systems

This page list the slides from the Workshop on the Regulation of HIV Test Systems

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June 14, 2022 at 09:09PM PEPFAR Activities within the Center for Biologics Evaluation and Research

This page details CBER's efforts in partnership with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). PEPFAR is the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world.

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June 14, 2022 at 08:19PM FDA Pharmacoviligance Course in Sweden

This page contains presentations from a two-day training seminar hosted by FDA CBER, “Application of Pharmacovigilance to U.S. FDA Regulatory Decisions for Vaccines” in Uppsala, Sweden in June 2012.

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June 14, 2022 at 07:48PM CBER-WHO Cooperative Agreement: Pharmacovigilance Capacity Building

FDA Center for Biologics Evaluation and Research (CBER) awarded a cooperative agreement grant.

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June 14, 2022 at 04:27PM Remarks by Commissioner Califf to the 2022 FDLI Annual Conference - 06/14/2022

Remarks by Robert M. Califf
Commissioner of Food and Drugs
2022 Food and Drug Law Institute Annual Conference
June 14, 2022
Washington, DC

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‘Ferocious’ Covid outbreak in Beijing traced to raucous bar - The Guardian

1. ‘Ferocious’ Covid outbreak in Beijing traced to raucous bar  The Guardian
2. Mass testing in Beijing after 'ferocious' Covid outbreak - BBC News  BBC News
3. Beijing Cases Hit Three-Week High as Covid Czar Urges Action  Bloomberg
4. Beijing tests millions over COVID cluster at bar  Reuters
5. Wild Partying at 24-Hour Bar in Beijing Leads to Thousands Isolated and Millions Tested After Covid Outbreak  The Daily Beast

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‘Ferocious’ Covid outbreak in Beijing traced to raucous bar - The Guardian

1. ‘Ferocious’ Covid outbreak in Beijing traced to raucous bar  The Guardian
2. Mass testing in Beijing after 'ferocious' Covid outbreak - BBC News  BBC News
3. Beijing Cases Hit Three-Week High as Covid Czar Urges Action  Bloomberg
4. Beijing tests millions over COVID cluster at bar  Reuters
5. Wild Partying at 24-Hour Bar in Beijing Leads to Thousands Isolated and Millions Tested After Covid Outbreak  The Daily Beast
6. View Full Coverage on Google News

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June 13, 2022 at 05:58PM Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

This is the draft guidance Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

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‘Ferocious’ Covid outbreak in Beijing traced to raucous bar - The Guardian

1. ‘Ferocious’ Covid outbreak in Beijing traced to raucous bar  The Guardian
2. Mass testing in Beijing after 'ferocious' Covid outbreak - BBC News  BBC News
3. Virus cluster at nightclub sets off new Beijing clampdown  San Francisco Chronicle
4. Beijing's bar-linked COVID outbreak is 'ferocious,' official says  Fox News
5. Beijing tests millions to stem 'developing' COVID cluster at 24-hour bar  Reuters.com
6. View Full Coverage on Google News

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Beijing's bar-linked COVID outbreak is 'ferocious,' official says - Fox News

Beijing's bar-linked COVID outbreak is 'ferocious,' official says  Fox NewsView Full Coverage on Google News

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Beijing's bar-linked COVID outbreak is 'ferocious,' official says - Fox News

1. Beijing's bar-linked COVID outbreak is 'ferocious,' official says  Fox News
2. Virus cluster at nightclub sets off new Beijing clampdown  The Associated Press
3. China Is Walking Back Virus Loosening Just Weeks After Reopening  Bloomberg
4. Beijing tests millions, isolates thousands over COVID cluster at 24-hour bar  Reuters
5. China struggles to stamp out Covid as Beijing, Shanghai reimpose some restrictions  CNBC
6. View Full Coverage on Google News

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Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing - Reuters

1. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Reuters
2. Beijing, Shanghai Resume Mass Testing as Covid Cases Rise  Bloomberg
3. China struggles to stamp out Covid as Beijing, Shanghai reimpose some restrictions  CNBC
4. Beijing bar-linked COVID outbreak 'explosive' in nature, government spokesman says  Reuters
5. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Yahoo News

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Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing - Reuters

1. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Reuters
2. Beijing, Shanghai Resume Mass Testing as Covid Cases Rise  Bloomberg
3. China struggles to stamp out Covid as Beijing, Shanghai reimpose some restrictions  CNBC
4. Beijing bar-linked COVID outbreak 'explosive' in nature, government spokesman says  Reuters
5. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Yahoo News
6. View Full Coverage on Google News

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Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing - Reuters

1. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Reuters
2. Beijing, Shanghai Resume Mass Testing as Covid Cases Rise  Bloomberg
3. China struggles to stamp out Covid as Beijing, Shanghai reimpose some restrictions  CNBC
4. Beijing bar-linked COVID outbreak 'explosive' in nature, government spokesman says  Reuters
5. Beijing warns of 'explosive' COVID outbreak, Shanghai conducts mass testing  Yahoo News

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Ukraine war: Mariupol officials fear cholera outbreak from infected water supply could kill thousands - Fox News

1. Ukraine war: Mariupol officials fear cholera outbreak from infected water supply could kill thousands  Fox News
2. Mariupol at risk of cholera outbreak as Russia struggles to provide basic services, says UK intelligence  CNN
3. Risk of Major Cholera Outbreak in Mariupol as Medical Services 'Near Collapse': UK  The Daily Beast
4. Cholera and other diseases could kill thousands in Ukraine's Mariupol - mayor  Reuters
5. Disease spike feared in Mariupol, Ukraine as dead bodies remain  New York Post
6. View Full Coverage on Google News

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Ukraine war: Mariupol officials fear cholera outbreak from infected water supply could kill thousands - Fox News

1. Ukraine war: Mariupol officials fear cholera outbreak from infected water supply could kill thousands  Fox News
2. Mariupol at risk of cholera outbreak as Russia struggles to provide basic services, says UK intelligence  CNN
3. Risk of Major Cholera Outbreak in Mariupol as Medical Services 'Near Collapse': UK  The Daily Beast
4. Cholera and other diseases could kill thousands in Ukraine's Mariupol - mayor  Reuters
5. Disease spike feared in Mariupol, Ukraine as dead bodies remain  New York Post

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June 10, 2022 at 09:57PM Blood Notices Proposed and Final Rules

List of blood notices, proposed and final rules

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June 10, 2022 at 06:25PM Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1

Products approval information are designated as Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents (BGRs) and are manufactured for use with the Ortho ID-Micro Typing System™.

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Risk of Major Cholera Outbreak in Mariupol as Medical Services 'Near Collapse': UK - The Daily Beast

1. Risk of Major Cholera Outbreak in Mariupol as Medical Services 'Near Collapse': UK  The Daily Beast
2. Mariupol at risk of cholera outbreak as Russia struggles to provide basic services, says UK intelligence  CNN
3. UK says Mariupol at risk of cholera outbreak  Reuters
4. Mariupol official says quarantine imposed amid cholera fears  The Hill
5. Cholera and other diseases could kill thousands in Ukraine's Mariupol - mayor  Reuters
6. View Full Coverage on Google News

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June 09, 2022 at 10:34PM Human Gene Therapy Products Incorporating Human Genome Editing

This is the draft guidance Human Gene Therapy Products Incorporating Human Genome Editing

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June 09, 2022 at 10:32PM Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

This is the draft guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

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June 09, 2022 at 10:11PM 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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June 09, 2022 at 08:40PM Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement - 06/14/2022

This is the CBER Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement.

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June 09, 2022 at 06:19PM Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

This is the draft guidance Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirementso

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June 09, 2022 at 05:06PM Hepatitis C

This page contains infectious disease test products for hepatitis c with supporting documents.

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June 09, 2022 at 04:39PM 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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June 09, 2022 at 01:08AM LUXTURNA

Is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s).

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June 09, 2022 at 12:01AM 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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June 08, 2022 at 09:13PM Other Recommendations for Biologics Manufacturers

We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

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June 07, 2022 at 11:44PM Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised)

FDA is issuing this guidance to provide clarity on meetings and user fees during the COVID-19 public health emergency.

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June 07, 2022 at 10:18PM Office of Compliance and Biologics Quality (OCBQ)

Office of Compliance and Biologics Quality (OCBQ)

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June 07, 2022 at 05:45PM MTS Anti-IgG Card

Indicated For in vitro blood banking reagent

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June 07, 2022 at 05:17PM 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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June 07, 2022 at 04:54PM Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement - 06/29/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement.

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June 07, 2022 at 04:54PM 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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June 07, 2022 at 02:35PM 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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June 07, 2022 at 03:14PM Labeling for CBER-Regulated Products

Labeling for CBER-Regulated Products

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June 07, 2022 at 01:50PM 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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June 06, 2022 at 07:50PM Blood Grouping Reagents - ORTHO Sera, ALBAclone

Product approval information is indicated for:
•ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).
•ORTHO Sera Anti-D (IAT) is for the in vitro detection of human Rh D positive red blood cells by the indirect antiglobulin test.
•ORTHO Sera Anti-Lea is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-Leb is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-N is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test.

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June 06, 2022 at 09:27PM Drugs@FDA Data Files

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

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June 06, 2022 at 07:43PM Devices Guidances

This page lists Medical Device Guidance documents.

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June 06, 2022 at 04:16PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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June 06, 2022 at 02:57PM KYMRIAH (tisagenlecleucel)

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

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June 03, 2022 at 07:08PM Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 - 125233, 125242)

Product approval information is indicated for the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test.

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June 04, 2022 at 04:52PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

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June 03, 2022 at 09:04PM Roster of the Vaccines and Related Biological Products Advisory Committee

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

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June 03, 2022 at 05:53PM 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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June 03, 2022 at 03:01PM Electromagnetic Compatibility (EMC) of Medical Devices

FDA is issuing this guidance to recommend information that should be provided in a premarket submission to demonstrate electromagnetic compatibility.

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June 02, 2022 at 11:31PM Blood Grouping Regents, BL 101728-34;103292

Blood Grouping Regents, BL 101728-34;103292
Reagent is used for testing human red blood cells by the room temperature saline tube test

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June 02, 2022 at 11:21PM Consumer Updates

Science-based health and safety information you can trust.

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China Claims Victory Over Shanghai's Covid Outbreak With New Cases Sliding - Bloomberg

1. China Claims Victory Over Shanghai's Covid Outbreak With New Cases Sliding  Bloomberg
2. Shanghai Lifts Covid Lockdown After Two Months  NBC News
3. After Shanghai lockdown, many struggle to pick up the pieces  Reuters
4. Fashion-obsessed Shanghai residents flocked to luxury stores on the first day of the city's reopening after its brutal lockdown  Yahoo News
5. Shanghai reportedly bans media use of the term ‘lockdown’ as lockdown ends  The Guardian
6. View Full Coverage on Google News

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June 02, 2022 at 09:06PM ALBAclone (Alba Bioscience Limited)

Product approval information is indicated for the in vitro detection and identification of human blood group antigens by direct agglutination.

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WHO says COVID in N.Korea likely 'getting worse, not better' - Reuters

1. WHO says COVID in N.Korea likely 'getting worse, not better'  Reuters
2. North Korea’s virus outbreak ‘getting worse, not better,’ WHO says  NBC News
3. WHO believes COVID getting worse, not better in North Korea  The Associated Press
4. COVID amid food insecurity: A perfect storm is brewing in N Korea  Al Jazeera English
5. North Korea’s Covid outbreak likely ‘getting worse’, WHO says  The Guardian
6. View Full Coverage on Google News

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June 01, 2022 at 07:12PM Genetic Systems rLAV EIA

Product approval information is new HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen.

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June 01, 2022 at 07:09PM Cambridge Biotech HIV-1 Western Blot Kit

Product approval information for urine specimen testing

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June 01, 2022 at 07:06PM ABBOTT HTLV-I/HTLV-II EIA

Product approval information is indicated for the detection of antibodies to human T-lymphotropic virus types I and II in human serum or plasma.

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June 01, 2022 at 04:39PM Chiron RIBA HCV 3.0 Strip Immunoblot Assay

Strip Immunoblot Assay including NS5 and c33c recombinant proteins and c100p, 5-1-1p and c22p synthetic peptides to detect antibodies to Hepatitis C Virus in human serum or plasma





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June 01, 2022 at 02:44PM 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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