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No Acceleration in Drug Approvals Despite ICT

by Rajshri on  November 21, 2009 at 8:25 PM Drug News
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No Acceleration in Drug Approvals Despite ICT
A statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare says that drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration.

Since the middle of the 1990s, FDA review intervals have been an important topic of discussion for the boards of major pharmaceutical companies and among consumer groups desperate to see new, improved products on the market. The issue has been raised by economists and financiers and in Congress.


John Kros and Christopher Keller of the College of Business, at East Carolina University, in Greenville, North Carolina, explain that the implementation of new Information Technology (IT) at the FDA has been a persistent target for reducing the time taken between an application and final approval. They have analyzed data on three main categories of new drugs are studied: New Drug Application (NDA), the Supplemental New Drug Application (SNDA) and the Abbreviated New Drug Application (ANDA).

The team points out that under the 1992 Congressional Prescription Drug User Fee Act (PDUFA), drug companies agreed to pay fees to the FDA and in turn, the FDA agreed to time limits on the review process for new drug applications. Then, the FDA Modernization Act of 1997 new funds and user fees were authorized. Both changes coincided with a significant increase in the use of IT at the FDA.

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