Introduction of 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."

     

    TYPES OF APPLICATION

    - INVESTIGATIONAL NEW DRUG (IND) APPLICATION

    - NEW DRUG APPLICATION (NDA)

    - ABBREVIATED NEW DRUG APPLICATION (ANADA: GENERICS

    - THERAPEUTIC BIOLOGIC APPLICATIONS (BLA)

    - DRUG APPLICATIONS FOR OVER-THE-COUNTER (OTC) DRUGS