STUDY DATA BY FDA

June 10, 2022

Are you planning to send a submission to the FDA?

Will this submission contain study data?

If the answer to these 2 questions has been yes, this brochure may be of your interest, since last year the FDA implemented the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.

Have a look at this brochure for an overview in detail:

STUDY DATA FDA

For further information, you can contact us at: info@asphalion.com

 

 

 

 

Search News & Events

  • Filter by category

Share

Related news and events

NEW | MHRA announces new recognition routes

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.

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