FDA Drug Approval Process:

CDER

Center for Drug Evaluation and Research; oversees clinical trial investigations for drug safety and effectiveness.

Preclinical Testing

Initial phase where drugs are tested in the lab to assess dosing and toxicity before moving to clinical testing.

IND application

Investigational New Drug application submitted by developers containing manufacturing info, animal safety data, and clinical protocol.

Clinical Trials

Required process consisting of 3 phases to test drugs for safety and effectiveness before approval.

NDA

New Drug Application; a request for FDA approval of a new drug, reviewed within 10-12 months.

How are drugs categorized for testing?

Drugs are grouped by common actions and effects on the body.

CDER

Center for Drug Evaluation and Research; oversees clinical trial investigations for drug safety and effectiveness.

Preclinical Testing

Initial phase where drugs are tested in the lab to assess dosing and toxicity before moving to clinical testing.

IND application

Investigational New Drug application submitted by developers containing manufacturing info, animal safety data, and clinical protocol.

Clinical Trials

Required process consisting of 3 phases to test drugs for safety and effectiveness before approval.

NDA

New Drug Application; a request for FDA approval of a new drug, reviewed within 10-12 months.

How are drugs categorized for testing?

Drugs are grouped by common actions and effects on the body.

Post-Market Monitoring

Monitors drug products after FDA approval; handles manufacturing changes and labeling supplements.

CMC

Includes chemistry, manufacturing, controls, and product quality tests.

Supplement Application

Application to make changes to the drug substance, drug product, production process, labeling, manufacturing equipment, or facilities.