WASHINGTON, Oct. 21 -- Food and Drug Administration has issued a notice called: Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability.
The notice was published in the Federal Register on Oct. 21 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or...