Posted 05 October 2017
By Zachary Brennan
Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs.
The CDER Direct NextGen Collaboration Portal allows potential ANDA applicants to initiate requests by uploading a meeting request package and to submit supporting documents, such as meeting presentation materials, requests for additional information from FDA and post-meeting comments.
The portal is intended to help FDA minimize manual data entry and support the agency’s GDUFA II performance goals, though FDA notes that potential applicants can still email pre-ANDA meeting requests to email@example.com.
As part of its push to advance the development of more complex generics, FDA on Monday also released two new draft guidances related to formal meetings between FDA and ANDA applicants, and ANDAs for certain highly purified synthetic peptide drug products. In addition, FDA on Monday released two other new draft guidance documents: One on refuse-to-receive standards for ANDA submissions and one on amendments to ANDAs under GDUFA II. The refuse-to-receive guidance also features new information on what happens when companies submit ANDAs with typographical errors.