FDA BRIEF: Week of Feb 13, 2017
FDA Drug Trials Snapshots and Diversity When Testing New Drugs
by: John J. Whyte, M.D., M.P.H., Director of Professional Affairs and Stakeholder Engagement, CDER
CDER piloted Drug Trials Snapshots program
- who participated in the studies
- information by sex, race, and age subgroups
- any reported differences in drug efficacy/safety by subgroup
Release of Drug Trials Snapshots Summary Report
- diversity of participants
- extent of efficacy/safety based on demographic factors
- will help facilitate discussion on clinical trial demographics.
- Now, anyone can go to the site and see the numbers for themselves in a quick snapshot.
POCA program is a software tool
- uses advanced algorithm to determine orthographic & phonetic similarity between two drug names
- can compare a drug name against multiple drug names in different “data sources”
- datasources: [email protected], RxNorm
POCA is web-based application that was originally developed for the Microsoft .Net Framework 1.1 and the Oracle 9i Database. It has now been upgraded to include the following:
- POCA Installation Files (ZIP – 84.3MB)
- POCA User Guide (PDF – 1.7MB)
- POCA Installation Guide (PDF – 3.1MB)
- POCA Read Me File (PDF – 398KB)
FDA-Approved Devices That Keep the Heart Beating
FDA-approved devices are used to treat various cardiovascular issues
- Automated external defibrillators (AEDs)
- Cardiac ablation catheters
- Cardiovascular angioplasty devices
- Cardiac pacemakers
- Implantable cardioverter defibrillators (ICDs)
- Prosthetic (artificial) heart valves
- Stents
- Ventricular assist devices (VADs)
Reporting problems with devices:
- MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- FDA Consumer Complaint Coordinator
- Phone
Data Standards in the Drug Lifecycle
Need for standard & uniform study data
- enables combining data from multiple studies
- help receive, process, review, archive submissions more efficiently and effectively
- modernize and streamline the FDA review process
