Final answer:
A pharmaceutical company must submit an Investigational New Drug (IND) application to the FDA before beginning human trials on a new drug therapy, after which the FDA reviews the application over a 30-day period. The correct option is C.
Step-by-step explanation:
Before a pharmaceutical company can proceed with human trials on a new drug therapy, it must submit an Investigational New Drug (IND) application to the FDA's Center for Drug Evaluation and Research (CDER). After submitting the IND application, there is a 30-day waiting period for the FDA to review it, before clinical trials involving human subjects can begin.
If there are concerns regarding the therapy's safety or protocol, the FDA can impose a clinical hold until these issues are resolved. Only after the drug has demonstrated safety and effectiveness during clinical trials will the company be eligible to submit a New Drug Application (NDA) to the FDA detailing manufacturing, packaging, monitoring, and administration plans for the new therapy.