September 30, 2024 at 10:30PM 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/hDxW6nQ) to determ

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September 30, 2024 at 07:04PM Center for Biologics Evaluation and Research (CBER) Product Approval Information

Center for Biologics Evaluation and Research (CBER) Product Approval Information

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USDA cut back on listeria testing nationwide, ahead of deadly Boar's Head outbreak - CBS News

1. USDA cut back on listeria testing nationwide, ahead of deadly Boar's Head outbreak  CBS News
2. Boar's Head plants nationwide now part of law enforcement investigation, USDA says  CBS News
3. Boar's Head faces legal scrutiny over deadly deli meat listeria outbreak, USDA says  ABC News
4. 10th death linked to Boar’s Head; one popular product discontinued forever  OregonLive
5. Inside The Chaos At Boar’s Head  Forbes

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September 27, 2024 at 06:13PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere, Fluzone High-Dose Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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10th death reported in Boar’s Head deli meat listeria outbreak - The Associated Press

1. 10th death reported in Boar’s Head deli meat listeria outbreak  The Associated Press
2. 10th listeria death tied to Boar’s Head deli meat  The Washington Post
3. Boar's Head fired sanitation boss at listeria-laden Va. plant after he flagged health, safety issues  New York Post
4. Boar’s Head Shutdown Deals a Hard Blow to a Battered Corner of Virginia  The Wall Street Journal
5. 10th death announced in listeria outbreak linked with Boar’s Head deli meat recall  CNN

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Death toll from Boar’s Head listeria outbreak reaches grim milestone - New York Post

1. Death toll from Boar’s Head listeria outbreak reaches grim milestone  New York Post
2. 10th listeria death tied to Boar’s Head deli meat  The Washington Post
3. 10th death reported in Boar’s Head deli meat listeria outbreak  The Associated Press
4. Boar’s Head Shutdown Deals a Hard Blow to a Battered Corner of Virginia  The Wall Street Journal
5. CDC: Tenth death reported in listeria outbreak linked to Boar's Head meats  USA TODAY

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Death toll from Boar’s Head listeria outbreak reaches grim milestone - New York Post

1. Death toll from Boar’s Head listeria outbreak reaches grim milestone  New York Post
2. 10th listeria death tied to Boar’s Head deli meat  The Washington Post
3. 10th death reported in Boar’s Head deli meat listeria outbreak  The Associated Press
4. Boar’s Head Shutdown Deals a Hard Blow to a Battered Corner of Virginia  The Wall Street Journal
5. CDC: Tenth death reported in listeria outbreak linked to Boar's Head meats  USA TODAY

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10th listeria death tied to Boar’s Head deli meat - The Washington Post

1. 10th listeria death tied to Boar’s Head deli meat  The Washington Post
2. CDC: Tenth death reported in listeria outbreak linked to Boar's Head meats  USA TODAY
3. Boar’s Head Shutdown Deals a Hard Blow to a Battered Corner of Virginia  The Wall Street Journal
4. Boar's Head fired sanitation boss at listeria-laden Va. plant after he flagged health, safety issues  New York Post
5. 10th death reported in Boar’s Head deli meat listeria outbreak  The Associated Press

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September 25, 2024 at 07:19PM 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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September 25, 2024 at 03:57PM An Acceptable Circular of Information for the Use of Human Blood and Blood Components

This is the final guidance An Acceptable Circular of Information for the Use of Human Blood and Blood Components.

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September 25, 2024 at 03:54PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

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September 24, 2024 at 10:07PM FDA Roundup: September 24, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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September 23, 2024 at 05:25PM Workshop on Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral Vectors - 11/14/2024

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on the clinical use of integration site analysis (ISA) during long term follow-up following administration of gene therapies with integrating viral vectors.

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September 23, 2024 at 03:12PM 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

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September 20, 2024 at 11:56PM 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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September 20, 2024 at 03:05PM Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program

ASCA Program; Basic Safety and Essential Performance Standards Specific Testing for ASCA; Biocompatibility Standards Specific Testing for ASCA

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September 20, 2024 at 03:05PM The Accreditation Scheme for Conformity Assessment (ASCA) Program

Guidance: ASCA Program; Basic Safety and Essential Performance Standards Specific Testing for ASCA; Biocompatibility Standards Specific Testing for ASCA

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A new genetic analysis of animals in the Wuhan market in 2019 may help find COVID-19's origin - The Associated Press

1. A new genetic analysis of animals in the Wuhan market in 2019 may help find COVID-19's origin  The Associated Press
2. New analysis of samples from Wuhan animal market supports its role as a central site of early spread of Covid-19  CNN
3. New research points to raccoon dogs in Wuhan market as pandemic trigger. It's controversial  NPR
4. Scientists again link covid pandemic origin to Wuhan market animals  The Washington Post
5. Evidence points to Wuhan market as source of covid-19 outbreak  New Scientist

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September 19, 2024 at 09:10PM OTP Events, Meetings, and Workshops

Office of Therapeutic Products Events, Meetings, and Workshops

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September 19, 2024 at 03:54PM Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr

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September 19, 2024 at 03:01PM Chemical Analysis for Biocompatibility Assessment of Medical Devices

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices.

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September 18, 2024 at 08:07PM Roster of the Blood Products Advisory Committee

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

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September 18, 2024 at 03:31PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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September 18, 2024 at 01:55PM 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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September 18, 2024 at 01:45PM Information About the Updated COVID-19 Vaccines

The Fall respiratory virus season is here, and people may have questions about the safety and effectiveness of the updated COVID-19 vaccines.

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September 17, 2024 at 08:33PM FDA Roundup: September 17, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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September 17, 2024 at 05:33PM 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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September 17, 2024 at 05:28PM Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants - 10/25/2024

FDA, CDC and NIH are hosting a public workshop entitled “Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants.”

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September 16, 2024 at 05:33PM Study Data Technical Conformance Guide - Technical Specifications Document

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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September 16, 2024 at 12:53PM CBER-Regulated Products with Supporting Documents

CBER-Regulated 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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The volatile recipe behind the Southern California summer fire outbreak - The Washington Post

1. The volatile recipe behind the Southern California summer fire outbreak  The Washington Post
2. California Wildfires updates: Firefighters score success in containment battle  ABC News
3. Mother of man accused in California wildfire says ‘he did not light that fire’  The Guardian
4. ‘It was Armageddon-like’: Mount Baldy Village united to save their town from Bridge fire  Los Angeles Times
5. Southern California Wildfires: Latest updates on Airport, Bridge, Line fires  KTLA Los Angeles

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Cooler weather brings relief to firefighters battling California’s three massive blazes - NBC News

1. Cooler weather brings relief to firefighters battling California’s three massive blazes  NBC News
2. Southern California Wildfires: Latest updates on Airport, Bridge, Line fires  KTLA Los Angeles
3. Mother of man accused in California wildfire says ‘he did not light that fire’  The Guardian
4. ‘It was Armageddon-like’: Mount Baldy Village united to save their town from Bridge fire  Los Angeles Times
5. The volatile recipe behind the Southern California summer fire outbreak  The Washington Post

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Cooler weather brings relief to firefighters battling California’s three massive blazes - NBC News

1. Cooler weather brings relief to firefighters battling California’s three massive blazes  NBC News
2. ‘It was Armageddon-like’: Mount Baldy Village united to save their town from Bridge fire  Los Angeles Times
3. The volatile recipe behind the Southern California summer fire outbreak  The Washington Post
4. Southern California Wildfires: Latest updates on Airport, Bridge, Line fires  KTLA Los Angeles
5. Mother of man accused in California wildfire says ‘he did not light that fire’  The Guardian

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Firefighters gain ground on 3 huge Southern California blazes - NPR

1. Firefighters gain ground on 3 huge Southern California blazes  NPR
2. The volatile recipe behind the Southern California summer fire outbreak  The Washington Post
3. ‘It was Armageddon-like’: Mount Baldy Village united to save their town from Bridge fire  Los Angeles Times
4. Southern California Wildfires: Latest updates on Airport, Bridge, Line fires  KTLA Los Angeles
5. Bridge Fire remains as SoCal's largest active fire at 52,000 acres  NBC Los Angeles

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Boar's Head indefinitely closes Virginia plant tied to deadly listeria outbreak, discontinues liverwurst - NBC News

1. Boar's Head indefinitely closes Virginia plant tied to deadly listeria outbreak, discontinues liverwurst  NBC News
2. Boar's Head discontinues product, closes facility linked to listeria outbreak 'indefinitely'  Fox Business
3. Boar’s Head Shuts Down Virginia Plant Tied to Listeria Deaths  The New York Times
4. Boar's Head shutters Virginia plant linked to listeria outbreak  Axios
5. Boar’s Head Closing Virginia Factory Tied to Deadly Listeria Outbreak  The Wall Street Journal

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September 13, 2024 at 08:44PM 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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Boar’s Head Shuts Down Virginia Plant Tied to Listeria Deaths - The New York Times

1. Boar’s Head Shuts Down Virginia Plant Tied to Listeria Deaths  The New York Times
2. Boar’s Head plant tied to deadly listeria outbreak to close indefinitely  The Washington Post
3. Boar’s Head to close Virginia plant linked to deadly listeria outbreak  CNN
4. Boar's Head shutters Virginia plant linked to listeria outbreak  Axios
5. Boar’s Head makes 'difficult decision' to close Virginia deli meat plant after deadly food poisoning outbreak  CBS 6 News Richmond WTVR

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September 13, 2024 at 06:13PM Types of FDA Inspections

The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products:

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September 12, 2024 at 06:53PM HEPLISAV-B

Indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

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September 12, 2024 at 03:42PM Join FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26

Project Community within the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) will hold the first National Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to increase cancer awareness within the Hispanic/Latino population.

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September 12, 2024 at 03:30PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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September 11, 2024 at 09:42PM Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

Electronic Submissions Revision 7

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September 11, 2024 at 03:03PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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September 10, 2024 at 09:32PM FDA Roundup: September 10, 2024

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

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September 10, 2024 at 08:46PM Drugs@FDA Data Files

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

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September 09, 2024 at 10:46PM OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs - 09/05/2024

The focus of this virtual town hall was to answer questions related to CMC data and information needed to support late-stage INDs for cell therapy and tissue-engineered products.

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September 09, 2024 at 07:35PM Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

Revision to the 2016 Patient Preference Guidance

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CDC issues warning over recalled eggs sold in three states - The Hill

1. CDC issues warning over recalled eggs sold in three states  The Hill
2. Egg recall is linked to a salmonella outbreak, CDC says: See which states are impacted  USA TODAY
3. Contaminated eggs sold in Illinois recalled after causing Salmonella infections  Chicago Tribune
4. FDA investigating new outbreak of infections from Salmonella Enteritidis; eggs likely source  Food Safety News
5. DHS identifies Salmonella infections linked to Milo’s Poultry Farms recalled eggs  WBAY

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A salmonella outbreak linked to recalled eggs sickens people in 9 states - NPR

1. A salmonella outbreak linked to recalled eggs sickens people in 9 states  NPR
2. Dozens of people sick across several states in salmonella outbreak linked to recalled eggs  Yahoo! Voices
3. CDC issues warning over recalled eggs sold in three states  The Hill
4. Egg recall is linked to a salmonella outbreak, CDC says: See which states are impacted  USA TODAY
5. DHS identifies Salmonella infections linked to Milo’s Poultry Farms recalled eggs  WBAY

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Egg recall issued by CDC is linked to a salmonella outbreak: See which states are impacted - USA TODAY

Egg recall issued by CDC is linked to a salmonella outbreak: See which states are impacted  USA TODAYView Full Coverage on Google News

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Dozens of people sick across several states in salmonella outbreak linked to recalled eggs - Yahoo! Voices

1. Dozens of people sick across several states in salmonella outbreak linked to recalled eggs  Yahoo! Voices
2. DHS identifies Salmonella infections linked to Milo’s Poultry Farms recalled eggs  WBAY
3. Egg recall alert: 42 people in Wisconsin sickened  WISN Milwaukee
4. Contaminated eggs sold in Illinois recalled after causing Salmonella infections  Chicago Tribune
5. CDC issues egg recall, warns of Salmonella outbreak in multiple states  WSB Atlanta

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September 05, 2024 at 05:33PM Assessing the Mechanism of Immunotherapy for Allergy and Allergic Asthma: Effect of Viral Respiratory Infections on Pathogenesis and Clinical Course of Asthma and Allergy

A description of Ronald Rabin's research program and related publications.

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September 05, 2024 at 05:26PM Developing and Evaluating Animal Models for Studying the Safety and Efficacy of Vaccines Against Anthrax, Staphylococcal Infections, and Pertussis

A description of Tod Merkel's research program and related publications.

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September 06, 2024 at 02:00PM Vaccines and Related Biological Products Advisory Committee September 20, 2024 Meeting Announcement - 09/20/2024

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) September 20, 2024 Meeting announcement and meeting materials.

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September 06, 2024 at 06:00AM 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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September 06, 2024 at 02:22AM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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September 05, 2024 at 11:39PM ACAM2000

ACAM2000 is a product approval indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

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September 05, 2024 at 02:50PM Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

Revision to the 2016 Patient Preference Guidance

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September 04, 2024 at 10:57PM Studies on Safety and Efficacy of Platelets and Other Transfused Blood Products

A description of J.G. Vostal's research program and related publications.

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September 04, 2024 at 07:46PM Diagnosis and Pathogenesis of Hepatitis Viruses That Impact the Safety of Blood and Related Products

David R. McGivern's research project "Diagnosis and Pathogenesis of Hepatitis Viruses That Impact the Safety of Blood and Related Products".

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September 04, 2024 at 12:26AM ABRYSVO

ABRYSVO is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, and pregnant individuals at 32 through 36 weeks gestational age.


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September 03, 2024 at 09:32PM KYMRIAH

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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September 03, 2024 at 09:02PM La FDA autoriza la vacuna contra el COVID-19 de Novavax actualizada para brindar una mejor protección contra las variantes que circulan actualmente

La FDA autorizó para uso de emergencia la vacuna contra el COVID-19 de Novavax actualizada (fórmula 2024-2025) con el fin de atacar más de cerca las variantes que circulan actualmente y brindar una mejor protección contra las consecuencias graves del COVID-19.

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September 03, 2024 at 03:20PM Mother Stem Institute, Corp. - 680118 - 08/20/2024

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

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