FDA BRIEF: Week of Feb 13, 2017

Drug Trials Snapshots Summary Report Thumbnail
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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

John Whyte

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.

READ

FDA Website


poca

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: Drugs@FDA, 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:

READ


EKG and human heart illustration (600x350)
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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:

READ

AEDs


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 processClick through the interactive “Data Standards in the Drug Lifecycle” Infographic

READ


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