China's COVID-19 outbreak developing rapidly, health official says - Reuters

1. China's COVID-19 outbreak developing rapidly, health official says  Reuters
2. China's Inner Mongolia quarantines tourists amid COVID-19 resurgence  Fox News
3. In China, 300 coronavirus cases means public shaming, marooned travelers and a nationwide dragnet  Yahoo News
4. More than 2,000 Inner Mongolia tourists quarantined over COVID-19 fears | TheHill  The Hill
5. ‘People are starting to wane’: China’s zero-Covid policy takes toll  The Guardian

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Supreme Court Won’t Block Maine’s Vaccine Mandate for Health Care Workers - The New York Times

1. Supreme Court Won’t Block Maine’s Vaccine Mandate for Health Care Workers  The New York Times
2. Supreme Court declines to block Maine health care employee vaccine mandate  CNN
3. Supreme Court declines to block vaccine mandate for health workers in Maine  NBC News
4. Despite outbreaks at Maine prisons and jails, workers aren't required to get vaccinated  pressherald.com
5. Supreme Court declines to block Maine vaccine mandate  Associated Press

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October 29, 2021 at 09:40PM FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.

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October 29, 2021 at 08:09PM BIMO/Team Biologics/Internet Surveillance/Other

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

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October 29, 2021 at 04:34PM 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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October 29, 2021 at 04:34PM Roster of the Blood Products Advisory Committee

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

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October 28, 2021 at 08:58PM KOVALTRY

KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant,
human DNA sequence derived, full length Factor VIII concentrate indicated
for use in adults and children with hemophilia A (congenital Factor VIII
deficiency) for:
 On-demand treatment and control of bleeding episodes
 Perioperative management of bleeding
 Routine prophylaxis to reduce the frequency of bleeding episodes

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October 28, 2021 at 05:31PM Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

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October 28, 2021 at 04:54PM Berinert

Product approval information is indicated for treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

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Why China Is the World’s Last ‘Zero Covid’ Holdout - The New York Times

1. Why China Is the World’s Last ‘Zero Covid’ Holdout  The New York Times
2. COVID-19 outbreak at women's prison, DOC data shows  KELOLAND News
3. Countries are reopening borders. But China isn't ready to live with the coronavirus.  The Washington Post
4. Covid Rulebreakers in Beijing Targeted as Virus Spreads  Bloomberg
5. Parts of northeast China on heightened alert as COVID-19 returns  reuters.com
6. View Full Coverage on Google News

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October 26, 2021 at 11:27PM Remarks by Acting Commissioner Janet Woodcock to the FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World - 10/26/2021

Remarks by Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World
October 26, 2021
White Oak, MD

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October 26, 2021 at 09:20PM 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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October 26, 2021 at 09:04PM Davati Medical Supply LLC - 615530 - 10/14/2021

Unapproved and Misbranded Product Related to Influenza Virus

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October 26, 2021 at 09:03PM Davati Medical Supply LLC - 615530 - 06/25/2021

Unapproved and Misbranded Product Related to Influenza Virus

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China locks down city of 4m people after six Covid cases detected - The Guardian

1. China locks down city of 4m people after six Covid cases detected  The Guardian
2. China Locks Down City of 4 Million to Subdue Covid Outbreak  The New York Times
3. China urges faster COVID-19 testing amid latest outbreak  Reuters
4. Fresh lockdowns in China as local Covid-19 infections spread to 11 provinces  CNN
5. China Giving Covid Shots to Three-Year-Olds as Outbreak Persists  Bloomberg
6. View Full Coverage on Google News

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If Beijing Olympics athletes aren't vaccinated, they'll be in quarantine for 21 days - NPR

1. If Beijing Olympics athletes aren't vaccinated, they'll be in quarantine for 21 days  NPR
2. China Local Travel Restrictions and Lockdown Are Back to Curb New Outbreak  Bloomberg
3. China, still pursuing ‘zero Covid,’ has reported dozens of cases in recent days.  The New York Times
4. Fresh lockdowns in China as local Covid-19 infections spread to 11 provinces  CNN
5. China battles new Covid outbreak with eye on Winter Olympics  Yahoo News
6. View Full Coverage on Google News

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China Locks Down Thousands in North to Contain Growing Outbreak - Bloomberg

1. China Locks Down Thousands in North to Contain Growing Outbreak  Bloomberg
2. Covid-19 Live Updates: Vaccine News, Ed Sheeran and the Latest  The New York Times
3. Chinese province closes tourist sites following virus cases  Associated Press
4. China Covid-19 Variant Outbreak Latest News on Virus Spread  Bloomberg
5. Chinese mainland reports 39 confirmed COVID-19 cases  CGTN
6. View Full Coverage on Google News

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Walmart Recalls Aromatherapy Spray Linked To Tropical Disease, 2 Deaths - HuffPost

1. Walmart Recalls Aromatherapy Spray Linked To Tropical Disease, 2 Deaths  HuffPost
2. CDC Announces Immediate Recall Of Popular Household Item  CBS Los Angeles
3. Walmart Aromatherapy Spray Linked to Mystery Outbreak of a Deadly Tropical Disease, Recall Issued  Gizmodo
4. Mystery of exotic infectious disease traced to aromatherapy room spray  CNN
5. Kansas resident among 4 in U.S. to fall ill from bacteria found in aromatherapy spray  Kansas City Star
6. View Full Coverage on Google News

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October 21, 2021 at 08:31PM Pregnant? Breastfeeding? Better Drug Information Is Coming

The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding.

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October 21, 2021 at 05:24PM Staff Fellow – Bioinformatics Reviewer

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) is recruiting a full-time Bioinformatics Reviewer to fill a staff fellow position.

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October 21, 2021 at 02:49PM Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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A salmonella outbreak is linked to onions from Mexico sold in the US - NPR

1. A salmonella outbreak is linked to onions from Mexico sold in the US  NPR
2. Salmonella outbreak linked to onions: Throw away onions if you don't know where they're from, CDC says  Yahoo Finance
3. CDC: Salmonella outbreak linked to onions imported from Mexico  Fox Business
4. Recall: Red, white and yellow whole onions identified as salmonella outbreak  ksltv.com
5. Florida among states listed with onions contaminated by Salmonella  WEAR
6. View Full Coverage on Google News

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October 20, 2021 at 10:51PM Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or “mix and match”) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

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October 20, 2021 at 09:48PM Remarks by Acting Commissioner Woodcock to the 2021 NORD Breakthrough Summit - 10/19/2021

Remarks by Janet Woodcock, MD
Acting Commissioner of Food and Drugs
2021 NORD Breakthrough Summit
October 19, 2021
Washington, DC

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October 19, 2021 at 11:49PM 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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New Zealand extends Auckland lockdown in battle on Delta variant - Yahoo News

1. New Zealand extends Auckland lockdown in battle on Delta variant  Yahoo News
2. 94 new Covid-19 community cases | nzherald.co.nz  nzherald.co.nz
3. New Zealand hits virus high, pushes vaccination as way out  ABC News
4. Covid-19 Delta outbreak: Government can't afford to rule out level 4 return - modeller Shaun Hendy  New Zealand Herald
5. New Zealand Covid update: Auckland to remain in lockdown even as fully vaccinated hit 70%  The Guardian
6. View Full Coverage on Google News

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October 18, 2021 at 07:06PM 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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Afghan refugee resettlement snarled by housing shortage, measles outbreak - New York Post

1. Afghan refugee resettlement snarled by housing shortage, measles outbreak  New York Post
2. U.S. Afghan Resettlements Slowed by Housing Shortage, Old Technology  The Wall Street Journal
3. US Afghan resettlements slowed by housing shortage, old technology  Livemint
4. View Full Coverage on Google News

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October 15, 2021 at 07:53PM Contacts in the Center for Biologics Evaluation & Research (CBER)

List of contact information in the Center for Biologics Evaluation & Research (CBER)

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October 15, 2021 at 02:55PM Flucelvax Quadrivalent

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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October 14, 2021 at 03:45PM Xenotransplantation Guidances

This page contains a listing of xenotransplantation guidances.

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WHO announces new expert group to investigate origins of the coronavirus and other outbreaks - The Washington Post

1. WHO announces new expert group to investigate origins of the coronavirus and other outbreaks  The Washington Post
2. Covid-19 vaccine boosters are 'immoral' and 'unfair', says WHO chief  CNN
3. WHO announces committee to probe COVID-19 pandemic origins  Fox News
4. WHO launches a new group to study the origins of the coronavirus  NPR
5. WHO says it may be 'last chance' to find COVID origins  swissinfo.ch
6. View Full Coverage on Google News

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October 13, 2021 at 05:38PM 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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October 13, 2021 at 03:01PM Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce GUDID submission requirements.

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October 12, 2021 at 06:12PM OBIZUR

Product approval information is indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.

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October 12, 2021 at 05:44PM Biosimilar and Interchangeable Biologics: More Treatment Choices

The FDA has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more.

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October 09, 2021 at 12:01AM Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine

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Jacinda Ardern facing biggest challenge yet as New Zealand switches to Covid suppression - The Guardian

1. Jacinda Ardern facing biggest challenge yet as New Zealand switches to Covid suppression  The Guardian
2. Auckland Covid rules to stay; Northland and Waikato at level 3 until Friday  nzherald.co.nz
3. New Zealand Extends Auckland Lockdown as It Rushes Vaccinations  Bloomberg
4. Covid 19 Delta outbreak: 35 community cases as Cabinet meets to discuss alert-level changes  New Zealand Herald
5. New Zealand braces for rising Covid cases as expert warns of potential explosion  The Guardian
6. View Full Coverage on Google News

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October 08, 2021 at 01:57AM 2021_10 Test Article FT 01

2021_10 Test Article some long description some long description.

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October 06, 2021 at 10:40PM PREA Non-Compliance Letters

PREA Non-Compliance Letters

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October 06, 2021 at 07:15PM Remarks by Acting Commissioner Woodcock at the Global Summit on Regulatory Science Research - 10/05/2021

Remarks by Janet Woodcock, MD
Acting Commissioner of Food and Drugs
Global Summit on Regulatory Science Research
National Center for Toxicological Research
Jefferson, Arkansas
October 5, 2021

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October 06, 2021 at 02:45PM Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.

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October 05, 2021 at 04:37PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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October 05, 2021 at 08:55PM 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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October 05, 2021 at 07:57PM 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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October 05, 2021 at 05:08PM 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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October 05, 2021 at 04:49PM 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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October 04, 2021 at 11:02PM Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021 - 10/26/2021

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

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October 04, 2021 at 09:35PM Janssen COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about FDA's Emergency Use Authorization of the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

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October 04, 2021 at 06:50PM Acceptance Review for De Novo Classification Requests

This guidance discusses De Novo acceptance policies and procedures, Refuse to Accept principles, and the Acceptance Checklist for De Novo Requests.

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October 04, 2021 at 03:53PM De Novo Classification Process (Evaluation of Automatic Class III Designation)

The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request. 

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October 01, 2021 at 10:16PM CBER Service Fellowship Program

provides a mechanism for the temporary employment, training, and professional development of promising postdoctoral scientists for a period of limited duration.

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October 01, 2021 at 10:04PM Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.

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October 01, 2021 at 10:04PM Vaccines and Related Biological Products Advisory Committee October 14-15 , 2021 Meeting Announcement - 10/14/2021 - 10/15/2021

This is the CBER Vaccines and Related Biological Products Advisory Committee October 14-15 , 2021 Meeting Announcement.

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October 01, 2021 at 08:48PM CBER Reports

This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports.

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October 01, 2021 at 08:12PM FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.

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October 01, 2021 at 04:12PM DG Gel Card 125445, 125449, 125450 - 125457

Product approval information is for:
•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse grouping, and D and Kell antigens on the surface of red blood cells in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test in human blood samples. This assay does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components.

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October 01, 2021 at 03:14PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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October 01, 2021 at 01:13PM Biological Product Deviation Reporting -- Blood Product Codes

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

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October 01, 2021 at 01:08PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes

This is the main page for the Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes.

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October 01, 2021 at 01:05PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/2oKXjsp) to determine if you must report an event. The list includes deviations from regulations, standards, and standard operating procedures (SOPs) that may affect the safety, purity, or potency of a product. These codes may not apply to all establishments because they include deviations and unexpected events related to SOPs implemented at individual establishments and may not be an industry standard or a procedure at your facility. The use of BPD Codes will assist the FDA in analyzing the data submitted and streamline the trend analysis.

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