History is written by people who attend meetings: especially when it comes to complex generics

The GRx+Biosims Conference held in Baltimore, MD from September 5-7, had a session on the GDUFA II Pre-ANDA Program for Complex Products on the last day, presented by FDA.

The presenter, Kris Andre, Associate Director of Regulatory Affairs, Office of Research and Standards, Office of Generic Drugs (OGD), discussed in detail the logistics and agency’s expectations related to the meetings for complex generics.

Get Your Priorities Straight

The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry.

Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission facility correspondence) related to the priority submissions were labor intensive.

Training Materials related to ICH Q11 Questions & Answers – Selection and Justification of Starting Materials; The Saga Continues

In August 2018, the ICH Q11 Implementation Working Group (IWG) published training material in the form of a PowerPoint presentation for better clarification of ICH Q11 Questions & Answers – Selection & Justification of Starting Materials.  The presentation can be found here: Q11 IWG – slide deck training material (choose “read only” option to view) .