Friday, July 29, 2022

July 29, 2022 at 10:02PM Center for Biologics Evaluation and Research Patient Engagement Program

Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on their diseases and treatments may help the center advance patient-focused medical product development.

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July 29, 2022 at 08:39PM FDA Provides Update on Agency Response to Monkeypox Outbreak

Today, the FDA is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics.

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July 29, 2022 at 05:11PM 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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Thursday, July 28, 2022

July 28, 2022 at 10:05PM National Immunization Awareness Month 2022 Bilingual 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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July 28, 2022 at 08:14PM How Gene Therapy Can Cure or Treat Diseases

Scientists have worked for decades on ways to modify or replace genes to treat, cure, or prevent illness. Advancements in science technology are changing the way we define disease, develop drugs, and prescribe treatments. The FDA has approved gene therapies for cancer, rare diseases.

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July 28, 2022 at 05:02PM 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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July 28, 2022 at 03:25PM Consumer Updates

Science-based health and safety information you can trust.

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Wednesday, July 27, 2022

July 27, 2022 at 02:44PM Susan P. King-Harris, D.P.M. - 591682 - 09/09/2019

Bioresearch Monitoring Program/IRB

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July 27, 2022 at 02:44PM Abington Memorial Hospital, IRC - 576854 - 08/28/2019

Bioresearch Monitoring Program/IRB

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July 27, 2022 at 02:22PM Invitrx Therapeutics Inc. - 581182 - 03/16/2020

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

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July 27, 2022 at 02:22PM Strong Fertility Center - 593262 - 12/11/2020

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

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July 27, 2022 at 02:22PM Utah Cord Bank LLC dba Utah Cell Bank - 614013 - 08/10/2021

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

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July 27, 2022 at 03:18AM Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting.

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Tuesday, July 26, 2022

July 26, 2022 at 07:54PM FDA's Critical Role in Ensuring Supply of Influenza Vaccine

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

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July 26, 2022 at 07:53PM La función fundamental de la FDA para garantizar el suministro de vacunas contra la influenza

Suministro de vacunas contra la influenza

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July 26, 2022 at 05:34PM General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Guidance for Industry : Clinical Pharmacology

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July 26, 2022 at 03:30PM 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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July 26, 2022 at 03:20PM Zhang Medical P.C. dba New Hope Fertility Center - 633890 - 06/24/2022

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

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Monday, July 25, 2022

July 25, 2022 at 03:28PM 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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Friday, July 22, 2022

July 22, 2022 at 09:48PM Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates - 05/24/2022

New event page to promote CBER's annual patient engagement and regenerative medicine workshop. The webpage will include information about the event, including the agenda and event details. We would like the event to be featured here: https://ift.tt/kCuayfv

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July 22, 2022 at 01:17PM Pentacel

For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday).

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July 22, 2022 at 06:48PM Real-Time Oncology Review (RTOR)

Real-Time Oncology Review (RTOR) Draft Guidance for Industry

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July 22, 2022 at 04:51PM Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry

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July 22, 2022 at 03:18PM Quadracel

Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series

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Thursday, July 21, 2022

July 21, 2022 at 04:42PM Clinical Investigator Inspection List E-K

Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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July 21, 2022 at 04:31PM Clinical Investigator Inspection List A-D

Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

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July 21, 2022 at 06:59PM 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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July 21, 2022 at 06:01PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

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July 20, 2022 at 03:59PM Tissue Notices, Proposed and Final Rules

List of Tissue Notices, Proposed and Final Rules

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Tuesday, July 19, 2022

July 19, 2022 at 10:33PM 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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July 19, 2022 at 08:35PM Labeling and Promotion Guidances

This page lists Labeling and Promotion Guidance documents.

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Monday, July 18, 2022

July 18, 2022 at 10:45PM Vaccine Notices, Proposed and Final Rules

List of vaccine notices, proposed and final rules

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Friday, July 15, 2022

July 15, 2022 at 10:52PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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July 15, 2022 at 10:51PM 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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July 15, 2022 at 10:08PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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July 15, 2022 at 07:39PM Hepatitis C

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

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July 15, 2022 at 08:03PM 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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July 15, 2022 at 02:47AM 2022_07 Test Article EDITED FT 01

2022_07 Test Article some long description some long description.

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Wednesday, July 13, 2022

July 13, 2022 at 11:04PM Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

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July 13, 2022 at 10:36PM Novavax COVID-19 Vaccine, Adjuvanted

Novavax COVID-19 Vaccine

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July 13, 2022 at 10:31PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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July 13, 2022 at 05:56PM Alinity m HIV-1

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System in human plasma from HIV-1 infected individuals.

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Tuesday, July 12, 2022

July 12, 2022 at 03:53PM Health Fraud Scams

Learn how to spot health fraud and avoid it.

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July 11, 2022 at 02:48PM Charter of the Allergenic Products Advisory Committee

This is the charter for the CBER Allergenic Products Advisory Committee.

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Friday, July 8, 2022

July 08, 2022 at 10:02PM 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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July 08, 2022 at 06:16AM 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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Thursday, July 7, 2022

July 07, 2022 at 07:54PM KYMRIAH (tisagenlecleucel)

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

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July 07, 2022 at 07:02PM 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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July 07, 2022 at 06:46PM Devices Guidances

This page lists Medical Device Guidance documents.

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July 07, 2022 at 03:44PM Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement - 06/07/2022

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement.

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Wednesday, July 6, 2022

July 07, 2022 at 01:10AM 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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July 06, 2022 at 06:25PM IMLYGIC

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

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July 06, 2022 at 03:53PM Influenza Virus Vaccine Safety & Availability

Influenza (flu) is a contagious respiratory disease that is caused by influenza viruses. Influenza viruses infect the respiratory tract (nose, throat, and lungs) in humans.

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July 06, 2022 at 03:47PM Guidance, Compliance & Regulatory Information (Biologics)

This is region content for the Site Studio Web Site Section 'Guidance, Compliance & Regulatory Information', Region 'MainContent'

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July 06, 2022 at 03:33PM Seasonal Information for Influenza Virus Vaccine

Seasonal Information for Influenza Virus Vaccine

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Tuesday, July 5, 2022

July 05, 2022 at 08:19PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone 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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July 05, 2022 at 05:50PM Flublok Quadrivalent

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.

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July 05, 2022 at 03:12PM Afluria, Afluria Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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July 05, 2022 at 03:06PM Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

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July 05, 2022 at 04:46PM 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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July 05, 2022 at 03:03PM FluLaval Quadrivalent

For active immunization of persons 6 months 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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July 01, 2022 at 08:44PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

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