This week the FDA issued a new draft guidance on Providing Regulatory Submission in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry. The guidance only affects submissions of promotional material to the FDA.
The major changes in this guidance are that the FDA will require that all 2253 and Pre-Clearance submissions be submitted electronically. This would not become mandatory until 24 months after this guidance is finalized.
Additionally, the FDA is encouraging, although not requiring, that 2253 submissions contain linked reference citations and reference PDFs. Traditionally, references are only included in the initial MLR submissions. Complying with this recommendation (while not mandatory) would add considerable complexity to the MLR approval process.
Electronic submissions are a positive improvement and will potentially allow a small amount of time to be shaved off our clients’ current 2253 submission process. As this guidance is finalized and adopted by the industry, we will need to meet with our clients to see how they plan to alter their review processes to accommodate these new requirements.
If you’d like to read the full and lengthy guidance document, it can be found here.
– Noah Beytin, Director, Regulatory Review