August 31, 2022 at 10:02PM BK180180: Arthrex Angel System Kit

This is the main page for the CBER 510k BK180180: Arthrex Angel System Kit.

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August 31, 2022 at 04:09PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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August 31, 2022 at 03:42PM Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.

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August 30, 2022 at 10:41PM Towards Longer-Acting Factor VIII Products with Better Purity

A description of Andrey Sarafanov's research program and related publications.

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August 30, 2022 at 10:33PM Evaluating the Host and Microbial Factors That Impact the Efficacy of Polysaccharide Vaccines

A description of Mustafa Akkoyunlu's research program and related publications.

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August 30, 2022 at 10:22PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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August 30, 2022 at 08:39PM California IVF Fertility Center - 598552 - 08/09/2021

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

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August 30, 2022 at 07:52PM BK170114: ASI Automated RPR test for Syphilis for use on the ASI Evolution

This is the main page for the 510K BK170114: ASI Automated RPR test for Syphilis for use on the ASI Evolution.

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August 30, 2022 at 05:08PM Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation – Screening and Testing of Stool Donors for Multi-drug Resistant Organisms

On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). Bacterial infections caused by multi-drug resistant organisms (MDROs) have

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August 29, 2022 at 03:13PM COMIRNATY

Vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) in individuals 16 years of age and older.

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August 25, 2022 at 03:20PM OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls - 09/29/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls. This event is the first in a series to answer questions from stakeholders about a variety of topics.

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August 26, 2022 at 01:54AM 2022_08 Test Article EDITED FT 01

2022_08 Test Article DD

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August 25, 2022 at 09:01PM 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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August 25, 2022 at 08:54PM FDA Informs Collection Establishments of CDC-Identified Potential Increased Zika Virus Risk to Blood and Tissue Safety in Florida’s Miami-Dade, Palm Beach, and Broward Counties

March 13, 2017: FDA is informing establishments that collect tissues (HCT/Ps) and blood components of potential increased risk due to Zika virus, so they may consider whether and how this new information impacts their practices

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August 24, 2022 at 09:58PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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August 24, 2022 at 05:39PM 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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August 23, 2022 at 09:39PM Drugs@FDA Data Files

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

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August 22, 2022 at 11:04PM Administrative Guidances

This page lists Administrative Guidance documents.

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August 22, 2022 at 08:40PM 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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Wendy’s pulls lettuce from sandwiches in three states amid E coli outbreak - The Guardian US

1. Wendy’s pulls lettuce from sandwiches in three states amid E coli outbreak  The Guardian US
2. E. Coli Outbreak In Several States Possibly Tied To Wendy's  NBC News
3. CDC: E. coli outbreak could be connected to popular fast food chain  WHIO
4. CDC: Indiana part of 4-state E. coli outbreak, possible Wendy's connection  FOX59 News
5. Wendy's pulling lettuce from menu due to outbreak  WNYT NewsChannel 13
6. View Full Coverage on Google News

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Wendy’s pulls lettuce from sandwiches in three states amid E coli outbreak - The Guardian US

1. Wendy’s pulls lettuce from sandwiches in three states amid E coli outbreak  The Guardian US
2. E. Coli Outbreak In Several States Possibly Tied To Wendy's  NBC News
3. CDC: E. coli outbreak could be connected to popular fast food chain  WHIO
4. Possible E. coli outbreak linked to Wendy's  11Alive
5. After E. Coli Outbreak, CR's Experts Warn Against Eating All Wendy's Sandwiches and Salads With Romaine Lettuce  Yahoo! Voices

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Wendy's pulls lettuce from sandwiches amid E. coli outbreak - AOL

1. Wendy's pulls lettuce from sandwiches amid E. coli outbreak  AOL
2. Possible E. coli outbreak linked to Wendy's  11Alive
3. CDC: E. coli outbreak could be connected to popular fast food chain  WHIO
4. Wendy’s pulls lettuce from sandwiches in three states amid E coli outbreak  The Guardian US
5. Wendy's pulling lettuce from menu due to outbreak  WNYT NewsChannel 13
6. View Full Coverage on Google News

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E. Coli Outbreak In Several States Possibly Tied To Wendy's - NBC News

1. E. Coli Outbreak In Several States Possibly Tied To Wendy's  NBC News
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
4. After E. Coli Outbreak, CR Experts Warn Against Eating All Wendy's Sandwiches and Salads With Romaine Lettuce  Yahoo! Voices
5. Michigan Reports E. coli Outbreak. More Than Half of the People Ate at Wendy's.  Deadline Detroit
6. View Full Coverage on Google News

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E. Coli Outbreak In Several States Possibly Tied To Wendy's - NBC News

1. E. Coli Outbreak In Several States Possibly Tied To Wendy's  NBC News
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
4. Michigan Reports E. coli Outbreak. More Than Half of the People Ate at Wendy's.  Deadline Detroit
5. Wendy's pulls lettuce from sandwiches in 3 states amid E. coli outbreak in after 37 people got sick  KSL.com

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Wendy's customers fall ill, CDC probes E.coli outbreak in four states - Reuters

1. Wendy's customers fall ill, CDC probes E.coli outbreak in four states  Reuters
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
4. E. Coli Outbreak In Several States Possibly Tied To Wendy's  NBC News
5. Eating at Wendy’s in Pa.? Your sandwich probably won’t have lettuce and there’s a good reason why  PennLive
6. View Full Coverage on Google News

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Wendy's customers fall ill, CDC probes E.coli outbreak in four states - Reuters

1. Wendy's customers fall ill, CDC probes E.coli outbreak in four states  Reuters
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
4. Wendy's removes lettuce from sandwiches in at least four states as part of E. coli outbreak  Yahoo Finance
5. Wendy's sued for E. coli in sandwich lettuce; BG woman hospitalized for 8 days  Sentinel-Tribune

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Wendy's customers fall ill, CDC probes E.coli outbreak in four states - Reuters

1. Wendy's customers fall ill, CDC probes E.coli outbreak in four states  Reuters
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
4. Wendy's removes lettuce from sandwiches in at least four states as part of E. coli outbreak  Yahoo Finance
5. 43 E. coli cases in Michigan, many hospitalized, linked to outbreak in 4 states  Detroit Free Press
6. View Full Coverage on Google News

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Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says - CNN

1. Wendy's restaurants associated with E. coli outbreak that sickened 37 people in four states, CDC says  CNN
2. Wendy's pulls lettuce from sandwiches at certain restaurants as CDC investigates E. coli outbreak  Fox Business
3. Wendy's removes lettuce from sandwiches in at least four states as part of E. coli outbreak  Yahoo Finance
4. CDC investigates an E. coli outbreak in 4 states after some Wendy's customers fell ill  NPR
5. Wendy's sued for E. coli in sandwich lettuce; BG woman hospitalized for 8 days  Sentinel-Tribune

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Lettuce on Wendy’s Sandwiches Potentially Linked to E. Coli Outbreak - The New York Times

1. Lettuce on Wendy’s Sandwiches Potentially Linked to E. Coli Outbreak  The New York Times
2. 43 E. coli cases in Michigan, many hospitalized, linked to outbreak in 4 states  Detroit Free Press
3. State investigating whether E. coli outbreak tied to Wendy’s restaurant food  MLive.com
4. Wendy's removes lettuce from sandwiches in at least four states as part of E. coli outbreak  USA TODAY
5. State says the E.coli illnesses could be connected to Wendy's  Detroit News
6. View Full Coverage on Google News

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Lettuce on Wendy’s Sandwiches Potentially Linked to E. Coli Outbreak - The New York Times

1. Lettuce on Wendy’s Sandwiches Potentially Linked to E. Coli Outbreak  The New York Times
2. E. coli outbreak in Ohio and Michigan under investigation by CDC after cases show linkage  WTOL11
3. State investigating whether E. coli outbreak tied to Wendy’s restaurant food  MLive.com
4. Wendy's removes lettuce from sandwiches in at least four states as part of E. coli outbreak  USA TODAY
5. State says the E.coli illnesses could be connected to Wendy's  Detroit News

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August 19, 2022 at 11:20PM 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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August 19, 2022 at 10:04PM 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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August 19, 2022 at 10:02PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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August 19, 2022 at 09:56PM Center for Biologics Evaluation and Research (CBER) 2022 Science Symposium Meeting Agenda

Center for Biologics Evaluation and Research (CBER) 2022 Science Symposium Meeting Agenda September 20-22, 2022

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August 19, 2022 at 09:55PM 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium - 09/20/2022

The public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER will include presentations by experts from academic institutions, government agencies and research institutions.

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August 19, 2022 at 08:02PM 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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August 19, 2022 at 05:20PM Medical Device Accessories - Describing Accessories and Classification Pathways

Provide guidance to about the regulation of accessories to medical devices. Intended to describe policy concerning the classification of accessories and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices.

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August 19, 2022 at 03:43PM ACAM2000 (Smallpox Vaccine) Questions and Answers

Questions about Smallpox and ACAM2000

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August 19, 2022 at 03:00PM Respuesta de la FDA a la viruela del mono

Respuesta de la FDA a la viruela del mono

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August 18, 2022 at 10:11PM Variant Creutzfeldt-Jakob Disease (vCJD) and Factor VIII (pdFVIII) Questions and Answers

Variant Creutzfeldt-Jakob disease, or vCJD, is a very rare, fatal disease that can infect a person for many years before making them sick by destroying brain cells.

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August 18, 2022 at 08:20PM 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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August 17, 2022 at 09:37PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

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August 17, 2022 at 09:37PM 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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August 17, 2022 at 08:11PM BK170108: Cyclone Concentrating System

This is the main page for CBER 510k BK170108: Cyclone Concentrating System.

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August 17, 2022 at 04:21PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

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August 17, 2022 at 02:50PM Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement - 10/06/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement.

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Wolfgang Petersen, director of Das Boot and Air Force One, dies aged 81 - The Guardian

1. Wolfgang Petersen, director of Das Boot and Air Force One, dies aged 81  The Guardian
2. Director Wolfgang Petersen Dies At 81; Hollywood Star Rose After ‘Das Boot’ To Include Blockbusters ‘The Perfect Storm,’ ‘Air Force One’ & ‘In The Line Of Fire’  Deadline
3. Wolfgang Petersen, Director of The NeverEnding Story and Outbreak, Has Died  Gizmodo
4. Wolfgang Petersen, German Commander of ‘Das Boot,’ Dies at 81  Hollywood Reporter
5. Blockbuster Film Director Wolfgang Petersen Dies of Cancer  The Daily Beast
6. View Full Coverage on Google News

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August 16, 2022 at 10:00PM Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)

Differences in genes can make someone more or less likely to benefit from a drug, suffer side effects, or require a dose that is different from other people. Such pharmacogenomic (PGx) information can be used to improve the medical decision-making process.

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August 15, 2022 at 09:27PM 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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August 15, 2022 at 06:40PM Consumer Updates

Science-based health and safety information you can trust.

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August 15, 2022 at 05:49PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine

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August 15, 2022 at 04:10PM PREA Non-Compliance Letters

PREA Non-Compliance Letters

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August 15, 2022 at 03:43PM Size and shape of human mesenchymal stem cells may predict future biochemical behavior potentially linked to supporting bone growth

Scientists at the US Food and Drug Administration (FDA) are studying characteristic of human mesenchymal stem cells (MSC) that can correlate with mineralization of MSC, which is a prerequisite step in bone formation.

Mineralization is the deposition of calcium by human mesenchymal stem cells (MSCs) that have received the appropriate stimulation. MSCs can turn into a variety of cells types, including those that form fat tissue, cartilage, or bones, depending on the stimulation. Many scientists, including those at FDA, are studying their properties for potential use for a variety of therapies aimed at restoring certain tissues in animals and humans.

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August 11, 2022 at 08:59PM FluMist

For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

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August 11, 2022 at 07:50PM FluMist Quadrivalent

For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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August 11, 2022 at 07:07PM 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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August 11, 2022 at 04:59PM Innovation and Regulatory Science

Innovation and Regulatory Science

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August 11, 2022 at 04:35PM Transfusion/Donation Fatalities

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

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August 10, 2022 at 10:12PM FDA assay predicts ability of mesenchymal stromal cells to suppress immune system activity

FDA assay predicts ability of mesenchymal stromal cells to suppress immune system activity
Scientists at the U.S. Food and Drug Administration (FDA) developed an assay that can predict the ability of human mesenchymal stromal cells (hMSCs) to suppress immune system activity.

The study represents an innovative use of morphological features of cells to rapidly predict future cell behavior.

hMSCs are cells derived from multiple tissue sources (such as bone marrow, fat, dental pulp, and umbilical cord) that have the unique ability to give rise to cells associated with bone, cartilage, and adipose tissue. There is also great interest in their ability to suppress unwanted immune system activation.

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August 10, 2022 at 09:04PM Cell analysis technique identifies subpopulations of stimulated mesenchymal stromal cells with in vitro immunosuppressive activity

Summary of research article on stem cell response to growth factors that makes them useful for regenerating or restoring tissues.

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August 10, 2022 at 08:22PM Biologics Research Projects

List of Biologics Research Areas

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August 10, 2022 at 08:07PM Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII) Questions and Answers

The US Public Health Service, including FDA, CDC, and NIH, believes that vCJD risk from US licensed pdFVIII products is most likely to be extremely small, although we do not know the risk with certainty.

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August 10, 2022 at 07:45PM Variant Creutzfeldt-Jakob Disease (vCJD) and Factor XI (pdFXI) Questions and Answers

Variant Creutzfeldt-Jakob disease, or vCJD, is a very rare, fatal disease that can infect a person for many years before making them sick by destroying brain cells.

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August 10, 2022 at 03:23PM Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement - 09/22/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement.

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August 10, 2022 at 03:22PM 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the CBER 2022 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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August 09, 2022 at 09:31PM Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

The FDA issued an emergency use authorization (EUA) for the JYNNEOS vaccine to increase vaccine supply by up to five-fold and to allow for individuals under 18 years of age determined to be at high risk of monkeypox infection to receive the vaccine.

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August 09, 2022 at 08:54PM Drugs@FDA Data Files

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

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August 09, 2022 at 07:24PM 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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August 09, 2022 at 07:21PM 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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August 09, 2022 at 07:07PM 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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August 08, 2022 at 11:36PM Roster of the Blood Products Advisory Committee

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

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August 08, 2022 at 11:15PM 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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August 08, 2022 at 09:45PM Potential vCJD Risk From US Licensed Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products: Summary Information, Key Points

In recent years, questions have been raised concerning the potential risk of variant Creutzfeldt-Jakob disease (vCJD - a rare but fatal brain infection) for recipients of plasma- derived clotting factors

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August 08, 2022 at 09:17PM Devices Guidances

This page lists Medical Device Guidance documents.

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August 08, 2022 at 06:56PM National Immunization Awareness Month 2022 Multilingual Social Media Toolkit

The social media messages and graphics below can help encourage your audiences to get vaccinated against #COVID19 and other infectious diseases.

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August 05, 2022 at 11:02PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

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August 05, 2022 at 09:25PM Recalls (Biologics)

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

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U.S. declares monkeypox outbreak a public health emergency - Reuters

1. U.S. declares monkeypox outbreak a public health emergency  Reuters
2. Stop the Spread—Why the Monkeypox Outbreak Must Be Contained | Opinion  Newsweek
3. We need a national action plan to contain monkeypox now  The Hill
4. Monkeypox in New York: Tracking cases in Albany and across the state  Times Union
5. Biden administration declares monkeypox a public health emergency  Fox News
6. View Full Coverage on Google News

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August 02, 2022 at 05:49PM 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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August 04, 2022 at 10:30PM Common Ingredients in U.S. Licensed Vaccines

Common ingredients found in vaccines that are commonly administered to healthy babies, children and adults are discussed to determine their safety and effectiveness.

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Biden administration declares monkeypox a public health emergency - ABC News

1. Biden administration declares monkeypox a public health emergency  ABC News
2. Biden administration plans to declare the monkeypox outbreak a public health emergency  CNN
3. As Monkeypox Spreads, U.S. Declares a Health Emergency  The New York Times
4. White House scrambles to play catch-up on monkeypox response  NBC News
5. Biden officials plan to declare monkeypox a public health emergency  The Washington Post

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US to declare health emergency over monkeypox outbreak - The Associated Press - en Español

1. US to declare health emergency over monkeypox outbreak  The Associated Press - en Español
2. US declares Monkeypox a national public health emergency | LIVE  Global News
3. Biden administration declares the monkeypox outbreak a public health emergency  CNN
4. As Monkeypox Spreads, U.S. Declares a Health Emergency  The New York Times
5. Stop the Spread—Why the Monkeypox Outbreak Must Be Contained | Opinion  Newsweek
6. View Full Coverage on Google News

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Biden officials plan to declare monkeypox a public health emergency - The Washington Post

1. Biden officials plan to declare monkeypox a public health emergency  The Washington Post
2. Biden administration plans to declare the monkeypox outbreak a public health emergency  CNN
3. White House scrambles to play catch-up on monkeypox response  NBC News
4. As Monkeypox Spreads, U.S. Plans to Declare a Health Emergency  The New York Times
5. US prepares to declare monkeypox outbreak a public health emergency  WRAL News

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August 04, 2022 at 06:00PM OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls - 09/29/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls. This event is the first in a series to answer questions from stakeholders about a variety of topics.

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August 04, 2022 at 05:37PM Section 8100: Communication

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

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August 04, 2022 at 04:39PM Instructions for Using the eBPDR System

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

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August 03, 2022 at 12:03AM Webinars and Outreach

CBER sponsored webinars for public and industry.

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August 02, 2022 at 11:58PM 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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August 03, 2022 at 10:02PM 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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August 03, 2022 at 07:35PM FDA Recognizes National Immunization Awareness Month

National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health.

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August 02, 2022 at 05:49PM 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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August 02, 2022 at 04:49PM Procleix Zika Virus Assay

The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, for transfusion. It is also intended for use in testing plasma or serum specimens to screen other living (heart-beating) donors of organs and Human Cells, Tissues, and Cellular and Tissue-Based Procucts (HCT/Ps), and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. The assay is intended for use in testing individual donor samples. It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from volunteer donors of whole blood components. This assay is not intended for use as an aid in diagnosis of Zika virus infection.

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August 02, 2022 at 04:07PM PROCLEIX WNV ASSAY

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

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August 02, 2022 at 03:49PM Procleix Ultrio Plus Assays

Product approval information for:
•Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
•Use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.

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August 02, 2022 at 03:36PM OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents

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

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California Gov. Gavin Newsom issues a state of emergency to help fight monkeypox - NPR

1. California Gov. Gavin Newsom issues a state of emergency to help fight monkeypox  NPR
2. California declares a state of emergency over monkeypox outbreak, following New York and Illinois  CNBC
3. California and Illinois declare states of emergency over monkeypox outbreak  CNN
4. NYC Health Commissioner Ashwin Vasan focuses wrongly on monkeypox stigma  Crain's New York Business
5. New York City, Illinois declare state of emergency over monkeypox  Fox News

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California Gov. Gavin Newsom issues a state of emergency to help fight monkeypox - NPR

1. California Gov. Gavin Newsom issues a state of emergency to help fight monkeypox  NPR
2. California declares a state of emergency over monkeypox outbreak, following New York and Illinois  CNBC
3. California governor declares state of emergency over monkeypox outbreak  CNN
4. NYC Health Dept. doc who called out PC monkeypox response slams COVID handling too  New York Post
5. New York City, Illinois declare state of emergency over monkeypox  Fox News

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August 02, 2022 at 12:00AM 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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July 28, 2022 at 04:34PM 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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August 01, 2022 at 03:23PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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