FDA requires drug makers to submit digital labeling info.

Share this article:
The FDA is requiring drug makers to submit labeling information digitally, a move it says will increase access and pave the way for use of other electronic healthcare tools.
The requirement, led by FDA's Center for Drug Evaluation and Research (CDER), is part of a larger effort to update drug labels.
The agency is expected to release new layout and content standards that could completely change the appearance of labels. "We are expecting to issue, at some point in the future, the physician labeling rule, which would require that all labels be formatted in a consistent, more easy-to-read
and understand format," CDER spokeswoman Crystal Rice told MM&M. Making the switch to the digital format means companies must submit labels that use embedded computer tags to enable the data to be searched. Over the next year, they will have to submit digital versions of currently marketed products. All label data will be grouped in one place, a public online archive kept by the National Library of Medicine located at http://dailymed.nlm.nih.gov, rather than on each drug maker's Web site. Eventually the FDA will provide the information at its own site, one that will include information on all FDAregulated products.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...