Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Drug Device Psg topic
No spam. Unsubscribe anytime.
PSG for drug‑device combos: presenter highlights immunogenicity and device performance for glucagon autoinjector
Summary
Using a glucagon autoinjector example, the presenter said PSGs include comparative API characterization, immunogenicity risk assessments for peptide APIs, and device‑focused BE studies including user‑interface evaluations for emergency‑use devices.
The presenter described a glucagon autoinjector as a representative drug‑device combination and said peptide APIs bring added complexity that requires rigorous impurity assessment and immunogenicity planning.
He explained the PSG would provide specific recommendations on comparative characterization studies to support API sameness and include footnotes on sample preparation and literature resources. For the device portion, the presenter said PSGs recommend in‑vitro BE tests and comparative device characterization and noted that user‑interface evaluations are required for drug‑device combination products used in emergency settings.
“Then for every single drug device combination product in the additional information session, we would have specific, detailed recommendation on how to evaluate the device component, from a user interface standpoint,” the presenter said. He added that PSGs are evolving and may include updated thinking on peptide source and acceptable development strategies when justified.
