US FDA considers more electronic submissions

22 December 2006

The US Food and Drug Administration has received recommendations from 24 firms and organizations about adopting new methods for the submission of drug reports and tendering of services. Comments from drugmakers and the general public will be accepted until February 16.

Speaking to the Government Computer News, a daily US magazine, Albert Edwards, director of regulatory affairs for TAP Pharmaceutical Products, said that the FDA should "move e-submissions from the 3%-5% participation level to a 95% plus level within the next two years."

At present electronic drug report submissions tend to be made by large drugmakers. Mr Edwards suggested that incentives for all firms to switch to electronic filing are needed.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight