New online portal for requesting pre-ANDA meetings for complex generic medicines with the FDA

With the new Generic Drug User Fee Act (GDUFA II) coming into play, the US Food and Drug Administration (FDA) have launched a new online portal which allows for companies to set up pre-ANDA (abbreviated new drug application) meetings. It is, for now, exclusively for complex generic products and will allow applicants to send a meeting request package with any supporting data or presentation material as well as allow the FDA to provide post-meeting comments and request for additional information. The aim of the portal is to reduce manual data entry, improve efficiency and support the GDUFA II performance goals.

During the transition, meeting requests can still be made using the usual email. The FDA have also published 4 draft guidance documents. The first to help applicants generate and submit meeting requests and the associated packages; and the second to help applicants make amendments to an ANDA under GDUFA II. A questions and answers guidance document for the refuse-to-receive standards that addresses general issues with the ANDA application process has also been issued. The final guidance document focuses on certain highly purified synthetic peptide drug products that refer to drugs listed as of rDNA origin and whether these products should be submitted as ANDAs or NDAs.

The guidance documents can be found here:

Pre-ANDA meeting requests under GDUFA  

Amendment to ANDA under GDUFA   

Refuse-to-receive standards 

ANDAs for highly purified synthetic peptide drugs