Regulatory Blog

In a pivotal move to reduce avoidable regulatory delays, On October 23, 2025 the FDA has made public the internal filing checklists used by the Center for Drug Evaluation and Research (CDER) to determine whether a submitted application—such as a New Drug Application (NDA) or Biologics License Application (BLA)—meets the threshold of being “complete and reviewable.” By publishing these checklists, FDA aims to provide greater transparency , enabling sponsors to align better

Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...