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FDA proposes automation of drug information

Pharmacy Regulation Resource, August 24, 2006

The Food and Drug Administration (FDA) on August 23 issued a proposed rule to automate the way pharmaceutical firms register themselves and list drugs with the FDA, according to a release.

The Electronic Drug Registration and Listing System aims to electronically list all drug products marketed in the United States. The current list is partially kept on paper.

Users of the list also include other government agencies, healthcare providers, and healthcare payers. The list currently includes more than 120,000 drug products and contains up-to-date information about specific drug formulations and manufacturers. The information includes ingredients, dosage forms, strengths, labeling, and manufacturer details. Drug makers would be required to submit establishment registration and drug listing information electronically.

Go here to read the FDA's press release.

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