While we wait and wait for the FDA to move forward on the eMDR, the agency made some important moves last week that demonstrate its rising commitment to receiving and handling device and drug information electronically.

On May 26, 2009, the FDA issued a draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.

To view the guidance, go to: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

While it contains no huge surprises, it is helpful because the draft guidance describes factors the FDA considers when evaluating ads and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate the FDA’s thinking on these factors.

And the agency is scheduled to publish this week a guidance called Providing Regulatory Submissions in Electronic Format — Drug Establishment Registration and Drug Listing. It’s designed to assist industry (e.g., manufacturers, repackagers, and relabelers) with the electronic submission of drug establishment registration and drug listing information.

Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive.

To view it, go to: http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm