Food and Drug Administration (FDA)

Centers for Disease Control and Prevention (CDC)

National Institutes of Health (NIH)

Environmental Protection Agency (EPA)

Phase I

Phase II

Phase III

Phase IV

To request approval for a new drug

To request approval for a new indication for an existing drug

To request approval for a new formulation of an existing drug

To request approval for a new dosage form of an existing drug

To request approval for a new biologic drug

To request approval for a new indication for an existing biologic drug

To request approval for a new formulation of an existing biologic drug

To request approval for a new dosage form of an existing biologic drug

To request approval for a new medical device

To request approval for a new indication for an existing medical device

To request approval for a new formulation of an existing medical device

To request approval for a new dosage form of an existing medical device

To request permission to conduct clinical trials of a new drug

To request permission to market a new drug

To request permission to conduct preclinical studies of a new drug

To request permission to manufacture a new drug

To request permission to conduct clinical trials of a new drug in the European Union

To request permission to market a new drug in the European Union

To request permission to conduct preclinical studies of a new drug in the European Union

To request permission to manufacture a new drug in the European Union

To request permission to market a new drug in the European Union

To request permission to conduct clinical trials of a new drug in the European Union

To request permission to conduct preclinical studies of a new drug in the European Union

To request permission to manufacture a new drug in the European Union

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form

A new biologic drug that has never been marketed before

A new biologic drug that has been marketed before but has been reformulated

A new biologic drug that has been marketed before but has been given a new indication

A new biologic drug that has been marketed before but has been given a new dosage form

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form

A new drug that has never been marketed before

A new drug that has been marketed before but has been reformulated

A new drug that has been marketed before but has been given a new indication

A new drug that has been marketed before but has been given a new dosage form