Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.
Good Manufacturing Practices (cGMP): When Do They Apply?
When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs: