FDAnews Drug Daily Bulletin


April 7, 2006

The FDA has announced a 60-day public comment period regarding its renewed requirement that labeling content for prescription drug and biological products be submitted electronically, in a form the agency can process, review and archive.

Specifically, the FDA is soliciting comment on: whether electronic submissions are necessary and have practical utility for the agency in doing its job; the accuracy of the agency's estimate of the burden placed on pharma manufacturers by the esubmission requirement, and ways to minimize that burden; and ways to enhance the quality, utility and clarity of the information to be collected.

"We estimate that the additional time necessary for submission of the content of labeling in electronic format for these applications will be less than 15 minutes," the agency said.

The FDA noted that esubmissions are made annually by about 75 companies with new drug applications, 160 with abbreviated new drug applications, and six with certain biological license applications.

The public comment period started on March 29. To view the notice, access http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0104-n000002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0104-n000002.pdf).