Data Standards: Improving Drug Review

Data Standards: Improving Drug Review

U.S. Food and Drug Administration

FDA CDER Regulatory Science: Improving Drug Review with Data Standards

U.S. Food and Drug Administration

About FDA’s Data Standards Program

U.S. Food and Drug Administration

Advancing the Development and Implementation of Analysis Data Standards

Study Data Standards Update for CBER: Your Guide to a Successful Submission

U.S. Food and Drug Administration

Introduction to Regulatory Science at the FDA

Understanding the New FDA Guidance on Data Standards

Rho

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019

U.S. Food and Drug Administration

Episode 7 - Improving Patient Care using AWS Health Care Services | Amazon Web Services

Amazon Web Services

Season 2 Episode 4 - Supporting FDA Drug Reviews With Data Insights

GovCIO Media & Research

IPPCR: Electronic Health Records and Clinical Data Interchange Standards

SEND for CBER, What You Need to Know

U.S. Food and Drug Administration

Real-World Evidence: How Big Data is Changing Scientific Standards

National Press Foundation

Unmet needs in regulatory science for generic drugs

Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020

U.S. Food and Drug Administration

CPP CODR Database — Data Standards: Why are they needed

Critical Path Institute

3 reasons healthcare needs data standards

Understanding FDA Study Data Standards

ANDA Performance/Operations Update (3of27) Generic Drugs Forum April 2018

U.S. Food and Drug Administration

Healthcare Data Standards 101