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Electronic labeling of drug info new must
Under a new rule, the Food and Drug Administration (FDA) will begin requiring electronic submission of labeling information for most drug applications.
The agency believes electronic labeling will improve the review process and speed the approval and public dissemination of labeling changes, enabling it to get up-to-date information on medications to doctors and patients quicker. The rule will take effect in June.
It applies to new drug applications, certain biological license applications, abbreviated new drug applications, supplements, and annual reports. The rule does not require full applications to be submitted electronically.
FDA commissioner Mark McClellan issued a prepared statement saying the use of modern information technology to improve public health is no longer optional at the agency.
Electronic submissions will cover the content of the package insert or professional labeling, including all text, tables and figures. The new labeling system is part of the FDA’s larger initiatives involving electronic medical records and electronic health information systems.
FDA says the final rule is intended to supplement existing requirements, which stipulate that copies of the label and labeling and specimens of enclosures be submitted. Indeed, copies of the package insert still must be submitted in an NDA, and they must be identical to the label and labeling and specimens of enclosures that appear in the package insert, on the immediate container, or in any other form distributed.
The complete rule can be viewed on-line at www.fda.gov.