Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.

Authors:
Archdeacon P; Grandinetti C; Vega JM; Balderson D; Kramer JM.

Journal:
Ther Innov Regul Sci

Publication Year: 2014

DOI:
10.1177/2168479013509382

PMCID:
PMC6038022

PMID:
30227498

View on PubMed View on PMC View Publisher
Journal Information

Journal Title: Ther Innov Regul Sci

Detailed journal information not available.

Publication Details

Subject Category: Pharmacology & Pharmacy

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
2/6
0.0% Transparent
Transparency Indicators
Click on green indicators to view evidence text
Core Indicators
Data Sharing
Code Sharing
Evidence found in paper:

"Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article."

Evidence found in paper:

"Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was conducted by in-kind contribution of effort by authors and organizations working with the Clinical Trials Transformation Initiative (CTTI; www.ctti-clinicaltrials.org ), as well as staff effort and meetings supported by CTTI funding (derived both from pooled fees from member organizations and from a cooperative agreement, U19FD003800, awarded to Duke University by the US Food and Drug Administration)."

Protocol Registration
Open Access
Additional Indicators
Replication
Novelty Statement
Assessment Info

Tool: rtransparent

OST Version: N/A

Last Updated: Aug 05, 2025