FDA Drug Approval Process:

1. CDER: Center for Drug Evaluation and Research; oversees clinical trial investigations used to ensure the safety & effectiveness of medications, safety devices, and medical strategies for humans.

STEP 1: Preclinical Testing:

• FDA requires all drugs to undergo preclinical testing in a lab, during this time the developer or sponsor will compile data on dosing and toxicity levels. Researchers will be evaluting the findings in order to see if the drug should move to the clinical testing

• preclinical testing = drugs go through preclinical testing, seeing the data & toxicity levels of drug.

STEP 2: The Investigational New Drug Process:

• drug developer will submit a IND application, it will contain manufacturing info, animal safety data, toxicity, clinical protocol, & info about the investigator.

• IND application: Investigational New Drug application

• after the IND application, a team will review the application & see if the drug is approved, if the drug is rejected then additional info will be required before a decision is made.

STEP 3: Clinical Trials:

• 3 phases of clinical trials testing are required before a drug may be considered for approval

• Phase 3: based on successful completion of phase 2, which also depends on completion of phase 1

STEP 4: New Drug Application:

• NDA = New Drug Application

• FDA will have 60 days to accept the application for review

• CDER will review and act on applications within 10-12 months after receiving the NDA.

• How do drugs get put in groups? they are put together by common actions & effects on the body.