VIDEO | Have a look at ASPHALION’s Q3 2024 highlights summary!

October 30, 2024

A lot of things have happened at Asphalion during these past three months, and we have summarized the highlights in a two minutes video. You can watch it here:

Hope you will enjoy it!

For any information request, you can contact us here: [email protected]

Search News & Events

  • Filter by category

Share

Related news and events

 NABIHEAL/PHOENIX | Regulatory Workshop

Last week, we had the pleasure of hosting a dynamic workshop in Barcelona at the CSIC- Residència d´investigadors, focused on the evolving regulatory landscape for

NEWS | Update from FDA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA. This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023- 2027” (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), submissions related to ANDAs that are not described above, or any other types of DMFs.

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