Joanne S. Eglovitch
Latest From Joanne S. Eglovitch
Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.
Technologies like head-mounted tablets became critical for method transfers, virtual inspections and more. Cloud-based submissions could be next …
Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.
It's another case where the pandemic spurs adoption of ways to speed the manufacture of vaccines and biologics that have been in development for years.
No more letters derailing applications over surprise drug GMP issues raised in remote records reviews, agency says. Now if sponsors get these CRLs, they will already know why.
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.