U.S., Mexico ask WHO for emergency declaration over deadly fungal outbreak - CBS News

1. U.S., Mexico ask WHO for emergency declaration over deadly fungal outbreak  CBS News
2. Suspected fungal meningitis infections in five Texas residents linked to surgery in Mexico  KENS 5: Your San Antonio News Source
3. CDC reports second death linked to surgery in Mexico  The Washington Post
4. Suspected fungal meningitis outbreak across 25 US states linked to Mexican surgical centers  WFLA
5. Second US death reported in fungal meningitis outbreak linked with surgeries in Mexico  East Idaho News
6. View Full Coverage on Google News

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May 26, 2023 at 07:47PM Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop - 03/30/2023

Immune Globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of Immune Globulins (IG).

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May 26, 2023 at 07:37PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

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May 26, 2023 at 02:16PM 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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May 25, 2023 at 05:34PM Moderna COVID-19 Vaccines

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

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May 25, 2023 at 04:25PM ATGAM

Renal allograft rejection
Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation.
Limitations of Use:
The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates

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May 25, 2023 at 02:54PM 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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May 25, 2023 at 02:53PM Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

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May 25, 2023 at 12:48AM 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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May 24, 2023 at 02:45PM Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Pharmacology/Toxicology

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May 19, 2023 at 09:56PM Industry Frequently Asked Questions

Frequently asked questions and the associated answers sorted by topic area

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Salmonella outbreak reported in 6 states, including Utah, linked to Papa Murphy's cookie dough - KSL.com

1. Salmonella outbreak reported in 6 states, including Utah, linked to Papa Murphy's cookie dough  KSL.com
2. CDC issues urgent warning over salmonella linked to COOKIE DOUGH  Daily Mail
3. Papa Murphy's cookie dough believed to be linked to Oregon salmonella cases  KOIN 6
4. Salmonella outbreak likely linked to Papa Murphy's raw cookie dough products  KOMO News
5. Officials issue warning about Papa Murphy's cookie dough after 18 people become sick  East Idaho News
6. View Full Coverage on Google News

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Officials issue warning about Papa Murphy's cookie dough after 18 people become sick - East Idaho News

1. Officials issue warning about Papa Murphy's cookie dough after 18 people become sick  East Idaho News
2. Salmonella outbreak likely linked to Papa Murphy's raw cookie dough products  KOMO News
3. Salmonella outbreak in WA likely linked to Papa Murphy’s cookie dough  The Seattle Times
4. Papa Murphy's cookie dough believed to be linked to Oregon salmonella cases  KOIN 6
5. Papa Murphy’s cookie dough linked to Oregon Salmonella outbreak  OregonLive
6. View Full Coverage on Google News

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May 23, 2023 at 10:04PM FDA Roundup: May 23, 2023

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

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May 23, 2023 at 08:39PM Drugs@FDA Data Files

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

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May 23, 2023 at 04:44PM SHINGRIX

This is the main page for the CBER SHINGRIX.

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May 22, 2023 at 09:33PM Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

These are the Meeting Materials for the Cellular, Tissue and Gene Therapies Advisory Committee

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May 22, 2023 at 07:51PM Blood Products Advisory Committee April 26, 2023 Meeting Announcement - 04/26/2023

This is the main page for the Blood Products Advisory Committee April 26, 2023 Meeting Announcement and meeting materials.

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May 22, 2023 at 02:19PM Cord for Life, Inc. - 572770 - 03/29/2019

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


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4th death linked to eye drops recalled by manufacturer - Insider

1. 4th death linked to eye drops recalled by manufacturer  Insider
2. Another death, more cases of vision loss linked to contaminated eye drops, CDC reports  ABC7 News Bay Area
3. Death toll rises in contaminated eye drops outbreak and more have lost their vision  KTRK-TV
4. Recalled contaminated eye drops linked to bacteria have led to a fourth death, CDC says  USA TODAY
5. 4th death, more vision loss cases linked to tainted eyedrops in US  The Tribune India
6. View Full Coverage on Google News

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Recalled contaminated eye drops linked to bacteria have led to a fourth death, CDC says - USA TODAY

1. Recalled contaminated eye drops linked to bacteria have led to a fourth death, CDC says  USA TODAY
2. Fourth person dies from bacteria linked to recalled eye drops, CDC says  Fox Business
3. Another death, more cases of vision loss linked to contaminated eye drops, CDC reports  ABC7 News Bay Area
4. One more dead in horrific eye drop outbreak that now spans 18 states  Ars Technica
5. Fourth Death Linked To Recalled Eye Drops, CDC Says  HuffPost
6. View Full Coverage on Google News

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Death toll from bacteria-infested eyedrops reaches 4: CDC - New York Post

1. Death toll from bacteria-infested eyedrops reaches 4: CDC  New York Post
2. Another death, more cases of vision loss linked to contaminated eye drops, CDC reports  ABC7 News Bay Area
3. Fourth person dies from bacteria linked to recalled eye drops, CDC says  Fox Business
4. Contaminated eye drops linked to more deaths as 14 people report vision loss  ABC News
5. One more dead in horrific eye drop outbreak that now spans 18 states  Ars Technica
6. View Full Coverage on Google News

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May 19, 2023 at 09:32PM FDA Roundup: May 19, 2023

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

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May 19, 2023 at 07:52PM 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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May 19, 2023 at 07:47PM FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

FDA approves Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene.

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May 19, 2023 at 12:57PM 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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May 19, 2023 at 03:24AM CARVYKTI

For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

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May 18, 2023 at 09:52PM 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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May 18, 2023 at 01:25AM HYQVIA

Indicated for the treatment of Primary Immunodeficiency (PI) in adults.

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May 17, 2023 at 06:19PM Remarks by Commissioner Robert Califf to the 2023 Food and Drug Law Institute (FDLI) Annual Conference - 05/17/2023

Remarks by Robert M. Califf, M.D.
Commissioner of Food and Drugs
2023 FDLI Annual Conference
Washington, DC
May 17, 2023

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May 17, 2023 at 05:04PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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May 16, 2023 at 11:27PM Artificial Intelligence and Machine Learning (AI/ML) for Drug Development

Computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making prediction

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May 16, 2023 at 08:55PM Drugs@FDA Data Files

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

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May 16, 2023 at 12:52AM FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - 11/15/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapy.

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May 12, 2023 at 09:49PM FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes - 05/16/2023

FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes. Virtual 2-day free public workshop.

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Making a Michael J. Fox Movie With Michael J. Fox's Movies - The New York Times

1. Making a Michael J. Fox Movie With Michael J. Fox's Movies  The New York Times
2. 'No violins': Michael J. Fox reflects on his career and life with Parkinson's  NPR
3. Michael J. Fox on suffering from Parkinson's: I broke my shoulder, elbow and hand  Marca English
4. How Michael J. Fox Got His Own Documentary  Hollywood Outbreak
5. Michael J. Fox Details Parkinson’s Battle in ‘Still’: How to Watch the Movie for Free  Billboard
6. View Full Coverage on Google News

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May 12, 2023 at 09:32PM FDA Roundup: May 12, 2023

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

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May 11, 2023 at 11:20PM Adacel

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

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May 12, 2023 at 01:53PM 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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May 11, 2023 at 10:38PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

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May 11, 2023 at 07:34PM Pfizer-BioNTech COVID-19 Vaccines

Information about Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccine boosters are now FDA-authorized for all doses.

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May 11, 2023 at 05:07PM Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies

While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.

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May 11, 2023 at 03:14PM Healthcare Providers (Biologics)

Resources for Healthcare Providers on biological products.

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May 11, 2023 at 03:11PM Regulation of the Blood Supply

Regulation of the Blood Supply

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May 10, 2023 at 06:42PM Have You Given Blood Lately?

FDA works to ensure the safety of the more than 14 million units of blood and blood components donated in the U.S. each year. Learn how FDA helps safeguard the blood supply and how you can donate blood.

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May 10, 2023 at 09:21PM Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - 04/27/2023

Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

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May 10, 2023 at 08:31PM OMISIRGE

Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

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May 10, 2023 at 07:19PM 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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May 10, 2023 at 03:08PM SPIKEVAX

COVID19 Vaccine, mRNA

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May 10, 2023 at 03:00PM FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

AI/ML can help bring safe, effective, and high-quality treatments to patients faster. This post highlights the discussion papers, “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products," and "Artificial Intelligence in Drug Manufacturing."

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May 05, 2023 at 06:44PM Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency

Guidance for Industry


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May 10, 2023 at 01:18PM Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement - 05/12/2023

This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials.

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May 09, 2023 at 03:31PM VOWST

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

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May 08, 2023 at 10:24PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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May 08, 2023 at 09:28PM 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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May 08, 2023 at 06:36PM Security Resources For Manufacturers of Biological Products

The physical security of biological products and the facilities in which they are manufactured and otherwise held is an important public health issue

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May 08, 2023 at 06:26PM Thimerosal and Vaccines

Thimerosal is a compound that has been widely used as a preservative in a number of biological and drug products. All vaccines routinely recommended for children 6 years of age and younger in the U.S. are available in formulations that do not contain thimerosal. The use of thimerosal as a preservative in vaccines has declined due to reformulation and development of new vaccines in single-use presentations.

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May 04, 2023 at 08:32PM COVID-19 Bivalent Vaccines

FDA authorized bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including an additional dose or doses for certain populations

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May 04, 2023 at 06:54PM 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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May 04, 2023 at 01:56PM Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products - 04/27/2023

Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products.

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May 03, 2023 at 10:17PM Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement - 10/14/2021

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

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May 03, 2023 at 10:03PM Kcentra

Product approval information is indicated for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.

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May 03, 2023 at 09:18PM 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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May 03, 2023 at 07:02PM ATGAM

Renal allograft rejection
Aplastic anemia (moderate to severe) in patients unsuitable for bone marrow transplantation.
Limitations of Use:
The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates

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May 03, 2023 at 12:57AM Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER): Real-World Evidence (RWE)

Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) Real-World Evidence (RWE)


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May 02, 2023 at 09:20PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

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May 02, 2023 at 06:44PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

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May 02, 2023 at 03:08PM Resources Related to Regenerative Medicine Therapies

Information on FDA’s Framework for the Regulation of Regenerative Medicine Products


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May 01, 2023 at 11:03PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine, Adjuvanted

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May 01, 2023 at 06:41PM 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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