Center For Biologics Evaluation And Research (cber) - Infectious Diseases

Relevant Publications

Lot-to-lot consistency, immunogenicity and safety of a quadrivalent split virion inactivated influenza vaccine in healthy population aged 9-59 years: A randomized, double-blind, controlled, phase IV clinical trial.

Issue Release: 2024

2023 in review: FDA approvals of new medicines.

Issue Release: 2024

Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

Issue Release: 2024

Editorial: First Regulatory Approval for Allogeneic Pancreatic Islet Beta Cell Infusion for Adult Patients with Type 1 Diabetes Mellitus.

Issue Release: 2023

United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies.

Issue Release: 2023

A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA\'s Benefit-Risk Framework.

Issue Release: 2023

2022 in review: FDA approvals of new medicines.

Issue Release: 2023

A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and Feasibility Study.

Issue Release: 2022

Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.

Issue Release: 2022

Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects.

Issue Release: 2022

Opportunities and challenges for applying model-informed drug development approaches to gene therapies.

Issue Release: 2021

Graphical Analyses in the Regulatory Evaluation of Gene Therapy Applications.

Issue Release: 2020

A Proposed Framework for Patient-Focused Policy at the U.S. Food and Drug Administration.

Issue Release: 2019

Clinical Pharmacology Review of Plasma-derived and Recombinant Protein Products: CBER Experience and Perspectives on Model-Informed Drug Development.

Issue Release: 2019

Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly.

Issue Release: 2019

Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice.

Issue Release: 2019

Regenerative Medicine Therapies for Rare Diseases.

Issue Release: 2018

Non-viral pathogens: Identification, relevance, and prevention for xenotransplantation.

Issue Release: 2018

Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial.

Issue Release: 2017

Additively manufactured medical products - the FDA perspective.

Issue Release: 2016

How Can Transmission Be Prevented?

What are the Technological Advances in Genomic Sequencing?

How Can Ventilation Be Optimized in Public Spaces?

How Can Measles be Prevented?

How are Flaviviridae viruses transmitted?

What are the Challenges?

How is HSV Transmitted?

Why Are Cohort Studies Important?

What Are Some Common Resistant Bacteria?

What is the Importance of Hygiene in Preventing Infectious Diseases?

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