The agenda for the May 5-6th CRCG FDA hybrid workshop, Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products, is now available
I am very excited to see a dedicated track for Nitrosamines! You DO NOT want to miss this session…
This seems to be one area where the FDA is potentially ahead of EMA etc. in terms of useful guidance.
Will be interesting to see if it has expanded out beyond the current FDA guidance, which talks about the addition of scavengers and whether or not BE studies are needed for the different classes, to include other types of reformulation of product, whether that is a change in the manufacturing process to avoid processes that introduce additional risk, or reformulation to replace risky raw materials.
