Center for Drug Evaluation and Research (CDER)

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

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Title:
New Drug Application: Statistics Section (Green Paper Folder)

New Drug Application: Statistics Section (Green Paper Folder)

Title:
New Drug Application: Clinical Data Section, (Tan Paper Folder)

New Drug Application: Clinical Data Section, (Tan Paper Folder)

Title:
Investigational New Drug Application (Red Polyethylene Folder)

Investigational New Drug Application (Red Polyethylene Folder)

Title:
Investigational New Drug Application, (Green Paper Folder)

Investigational New Drug Application, (Green Paper Folder)

Title:
Investigational New Drug Application (Orange Paper Folder)

Investigational New Drug Application (Orange Paper Folder)

Title:
Drug Master File (Red Polyethylene Folder)

Drug Master File (Red Polyethylene Folder)

Title:
Drug Master File (Blue Polyethylene Folder)

Drug Master File (Blue Polyethylene Folder)

Title:
New Drug Application: Chemistry Section (Red Paper Folder)

New Drug Application: Chemistry Section (Red Paper Folder)

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