Profile

Dear PQ Team - please see below for likely a highly relevant guidance for PQ. FDA has published a draft guidance for industry titled "Container Closure Systems for Human Drugs and Biological Products" for public comment (posted 14 August 2026). The comment deadline is 13 October 2026. The Federal Register ...

Dear AAPS Pharmaceutical Quality team, AAPS (led by the Translational and Clinical Science Community) is going to convene to submit comments, generally, on these 17 PSGs for peptide products. The team is meeting Aug 19 at 1pm EST. Do we have any PQ members who wish to join this team? There may be ...

Dear AAPS Pharmaceutical Quality team, AAPS is considering a response to the FDA docket on Quantitative Medicine Innovation Network (QMIN), which has announced a Request for Information (RFI). More information is below. Does the PQ community wish to provide information? From my review, this guidance ...

Dear AAPS Pharmaceutical Quality team, AAPS is considering a response to the FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964). Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products From my review, this guidance would ...

Dear AAPS Pharmaceutical Quality team, AAPS is considering a response to the FDA draft guidance on Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing, for public comment (issued April 2026; comments close 14 July 2026). The guidance is here: https:/ ...

Dear AAPS Pharmaceutical Quality team, AAPS is considering a response to four draft US Pharmacopoeia analytical method standards. Please see below message. The four standards are: - Methods for the Analysis of Bevacizumab - https://emergingstandards.usp.org/emerging-standard/methods-analysis-bevacizumab ...