Letter to OMB Regarding Electronic Labeling Rule

February 7, 2014

Excerpt:

As the pharmaceutical market has evolved, electronic data interchange has become more common for commercial and regulatory interactions. For example, the Food and Drug Administration (FDA) has required manufacturers to submit drug labeling information in an electronic format since 2005. Additionally, electronic labeling has been cited by the FDA as allowing for the efficient distribution of updated information to health care providers about a prescription drug. Consequently, the agency has repeatedly included electronic labeling in its semi-annual regulatory agenda. However, FDA’s specific plans regarding electronic labeling have yet to be made public.

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To read a related press release, click here.

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