FDA tests electronic submissions from firms

One more step with the FDA beefing up their information systems. I would think that most pharma companies would more than likely jump on this opportunity in a hurry as their business has been one of the most progressive in health care, with even pharma representatives who carry around Tablet PCs in order to capture a digital signature as an example when making a delivery of samples. They talk about doctors being slow to go paperless, the FDA was in the same mode until recently transparency required some accounting to be done, and all the old policies and procedures just made their way out in the the wash. Now about those bonuses…..??

This is using XML formatting, the same thing that makes the feeds from this blog available and visible. By June 2009, all submissions will need to be electronic. Perhaps someday those XML feeds can also make it to Twitter as well. BD

The Food and Drug Administration has established a pilot program and draft guidance for drug companies to voluntarily submit registration information and their list of pharmaceutical products in an electronic format, the agency said in a draft guidance published today in the Federal Register. The requested information is fundamental to many processes the agency uses for surveillance for serious drug reactions, inspection of facilities used for drug manufacturing and processing, and monitoring imported drug products inspection, the FDA said.