Electronic SPL Procedure Remains on Track

The FDA rejected a complaint that it underestimates the amount of time it takes drugmakers to develop standard operating procedures (SOPs) for electronic submission of drug establishment registration and drug listing information. The agency received the comment in response to a draft guidance it issued last July on creating and submitting electronic Structured Product Labeling (SPL) files. The agency says in a notice that developing an SOP for the process will take drugmakers an average of 40 hours, plus one hour a year to review and update it.
Washington Drug Letter