FDA | New draft guidance for PDUFA products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This draft guidance, when finalized, will represent the current thinking of the Agency on this topic.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: [email protected]

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

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | DIA RAPS Regulatory Policy Forum

Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum.
Designed specifically for regulatory policy leaders, senior decision makers, and regulators across the pharmaceutical community, this summit will explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena—including research, development and manufacturing—in Europe for decades to come.

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