OTOMAX SOFTWARE SOFTWARE
The framework proposed in this notice focuses not on prescription drug-use-related software itself, but rather on the output of such software that is presented to the end user. Recognizing the opportunities for increased use of digital technology with prescription drugs, the Agency is proposing a framework that would provide prescription drug sponsors the flexibility to develop and disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors' communications about their products. The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use Start Printed 75with one or more of their prescription drug products. Notice establishment of a public docket request for comments. Additional Issues for Considerationįood and Drug Administration, HHS. Output of Prescription-Drug-Use-Related Software That Has Been Cleared or Approved by CDRH Output of Prescription Drug-Use-Related Software That Contains Multiple Functions Prescription Drug-Use-Related Software Output That Constitutes Promotional Labeling Information About Prescription Drug-Use-Related Software Output That May Be Included in FDA-Required Labeling Prescription Drug-Use-Related Software Output as Labeling for a Prescription Drug
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OTOMAX SOFTWARE PDF
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