Feeling uncertain about LDR compliance?
The mandate by the FDA requiring manufacturers of products distributed under a BLA to submit LDRs in electronic SPL format goes into effect on June 10, 2015.
Take the first step in defining your LDR implementation strategy by downloading a free LDR readiness kit to assess the approach best suited to your organization.
Your kit will include:
- Detailed information on SPL conversion submission methods
- Description of new fields required for submission
- A step-by-step submission guide