Drug Development and Approval
I) Responsiblity of Research Facility
1. Development and research of new drug
2. Test drug and evaluate its safety and effectiveness
3. Obtain a research permit
4. Perform clinical trials
5. Submit all data to the FDA for review
II) Process of FDA Approval
1. Each of the five Offices of Drug Evaluation oversees the drug for certain medical conditions
2. If the drug is determined to be safe and effective, it will be approved
* Note: All research facilities are subjected to several FDA inspections throughout the course of a study. If at any time the FDA determines that the company has not complied with Good Laboratory Practices (GLPs), the study may be disqualified.