fda submissions

How to include the REMS for NDAs, ANDAs and BLAs in SPL format?

FDA has just released a the guide to include them and in two years it will become mandatory

FDA has just released a the guide to include them and in two years it will become mandatory
September 7, 2017
FDA has released a guidance document for Providing Regulatory Submissions in Electronic Format – Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.
This guidance document provides information on how to include the REMS (The Risk Management Plan in US) for NDAs, ANDAs and BLAs in SPL format.
Applicants must submit the content of their REMS document in SPL format, 24 months after this guidance is finalized.  A submission that doesn´t comply and will not be filed or received by FDA.
In case of any question with regards to REMS or SPL format, please contact us at fda@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

Introducing Adi Ickowicz!

We are happy and proud to welcome Adi Ickowicz as Senior Principal to further strengthen our Medical Devices team! From Asphalion, we thank Adi for

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting