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

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

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

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

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