FDA | New draft guidance for PDUFA products

October 11, 2023

The US Food and Drug Administration (FDA) has released an updated preliminary advisory document aimed at assisting sponsors in comprehending the various categories of meetings they can seek to address inquiries related to their applications, while also outlining the timeframes associated with these requests.

The guidance adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings.

This draft guidance, when finalized, will represent the current thinking of the Agency on this topic. Read the full guidance HERE.

Do you need assistance for FDA requirements? Reach out to us!

Send us an email at: info@asphalion.com

Or schedule a free 30-minutes meeting: SCHEDULE A MEETING

Search News & Events

  • Filter by category


Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

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