It’s been about six months since I last checked in with news from the Pharma & Biopharma Outsourcing Association (PBOA). At the time, the PBOA was immersed in negotiations with FDA and other industry groups for the reauthorization of the Generic Drug User Fee Amendments (GDUFA). Because negotiations were ongoing, I couldn’t discuss how they were progressing—beyond the need for confidentiality, it was also a very fluid process. Now, I’m happy to report, industry’s negotiations with FDA hav...