FDA | Biologics Effectiveness and Safety (BEST)

Publications & Presentations

Transparency is a fundamental principle of the operations of the CBER Surveillance Program including the BEST Initiative, Sentinel System, CMS collaboration, and others. Knowledge acquired from the surveillance activities is placed in the public domain. To accomplish this aim, information concerning surveillance activities will be made available on the BEST website and other locations when appropriate.

Most Recent Publications & Presentations Assessments

Title

Date

Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020

Vaccine. 2022 Nov 08 (website)

11/08/2022

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

JMIR. 2022 Sep14 (website)

09/14/2022

Active Surveillance of Vaccine Safety: Intermediate/Advanced Topics in Vaccine Epidemiology (ICPE 2022), Hui Lee Wong, PhD

08/25/2022

Active, surveillance, vaccine

Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19

PLoS One. 2022 Aug 18 (website)

08/18/2022

Setting The World on FHIR

HL7 Case Study. 2022 Jul (website)

07/2022

Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases, February-November 2020

BMC Public Health. 2022 Jun 18 (website)

06/18/2022

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases

Lancet. 2022 Jun 11 (pdf)

This publication also includes a supplementary appendix and commentary.

06/11/2022

Risk, myocarditis, pericarditis, COVID-19 mRNA vaccinations, administrative claims

The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing

Frontiers. 2021 Dec 22 (website)

12/22/2021

Vaccine exposure during pregnancy among privately and publicly insured women in the United States, 2016–2018

Vaccine. 2021 Oct 01 (pdf)

10/01/2021

Vaccine exposure, pregnancy, Insured women

Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database

Drug Saf. 2021 Sep 30 (website)

09/30/2021

Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database

PLoS One. 2021 Jul 01 (pdf)

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253580

07/01/2021

Acute myocardial infarction ICD-10, administrative claims, algorithm

CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System

2021 FDA Science Forum. 2021 May 26 (website)

Presentation begins at the 2:12:00 mark

05/26/2021

Development of an Application That Semi-Automates Clinician Verification and Reporting of Transfusion Allergic Reaction Cases

AABB. 2020 Oct 3-5 (website)

10/03-05/2020

Development of a SMART-on-FHIR-enabled Semi-Automated Adverse Event Validation and Reporting Application

FHIR DevDays. 2020 June (website)

06/2020

An FDA-CBER Update on Surveillance, Epidemiology and Risk Management Approaches for Biologics

DIA PV Meeting Presentation 2020 (pdf)

01/29/2020

DIA PV and Risk Management Strategies Conference

Biologics Effectiveness and Safety (BEST) Initiative: Sentinel Public Meeting 2019

Sentinel Public Meeting Presentation 2019 (pdf)

04/03/2019

Sentinel Public Meeting 2019

Biologics Effectiveness and Safety (BEST) Initiative: First Year

OHDSI Symposium Presentation 2018 (pdf)

10/12/2018

OHDSI Symposium 2018