FDA’s Center for Drug Evaluation and Research (CDER) is responsible for regulating manufacturing, testing and importation of pharmaceutical drugs in the US. This includes new drug approvals, abbreviated new drug approvals (generics), over-the-counter drugs, animal drugs and biologics. A drug is defined as:
- A substance intended for use in diagnosis, cure, mitigation, treatment, or prevention of the disease;
- Substances (other than food) intended to affect the structure or any function of the body;
- Or a substance intended for use as a component of a medicine but not a device or component of a device.
Research Topic