How many days after FDA approval of an NDA must the sponsor submit the content of labeling in SPL format?

The FDA requires that the sponsor of a New Drug Application (NDA) submit the content of labeling in Structured Product Labeling (SPL) format within 14 days following the approval of their NDA. This requirement is part of the FDA's efforts to ensure that drug labeling is standardized and easily accessible, which helps improve safety and efficacy information for healthcare professionals and patients.

Submitting the labeling in SPL format promptly after approval is important because it allows medical professionals to have timely access to vital information regarding the drug's proper use, dosing, warnings, and potential side effects. This format is part of a larger initiative to enhance the clarity and usability of drug information.

While other time frames such as 7 days, 21 days, and 30 days might seem reasonable, the specific regulation mandates the 14-day time frame, underscoring the FDA's commitment to swift dissemination of essential product information post-approval.