Final answer:
An Investigational New Drug (IND) application is submitted to the FDA's Center for Drug Evaluation and Research (CDER) as part of the approval process for a new therapy. If approved, the developers can submit a New Drug Application (NDA) detailing manufacturing, packaging, monitoring, and administration details.
Step-by-step explanation:
An Investigational New Drug (IND) application is submitted to the FDA's Center for Drug Evaluation and Research (CDER) as part of the approval process for a new therapy. It includes significant laboratory data from animal trials and is followed by a waiting period while the FDA reviews the application.
If the FDA perceives any issues, they can order a "clinical hold" until the problems are addressed. Once the therapy meets FDA standards for effectiveness and safety, the developers can submit a New Drug Application (NDA) outlining manufacturing, packaging, monitoring, and administration details.