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  1. Development & Approval Process (CBER)

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products

New Drug Application (NDA):

Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER).

Examples of CBER NDAs include but are not limited to:

  • Red blood cell processing solution, such as for rejuvenation of red blood cells concentrate
  • Products indicated for treatment of hypovolemia when plasma volume expansion is desired
  • Anticoagulant solution used in the collection of un-anticoagulated donor blood samples
  • Sterile bags containing anticoagulant intended for collection of umbilical cord blood
  • Products intended for use as fluid replacement and plasma volume expansion in the adjunctive treatment of certain types of shock or impending shock, such as burns, surgery, hemorrhage and other trauma
  • Solution designed to replace a proportion of the plasma used in storage of leuko-reduced apheresis platelets under standard blood banking conditions

For more information, visit the CDER website: New Drug Application (NDA)

Abbreviated New Drug Application (ANDA):

There are only a few ANDAs currently regulated at CBER, e.g., ANDAs related to blood transfusion products. Most ANDAs are reviewed by CDER.

For more information, visit the CDER website: Abbreviated New Drug Application (ANDA)

Additional Resources:

Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated Products
Biologics Guidances
Biologics Procedures (SOPPs)
Master Files for CBER-Regulated Products
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

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Office of Communication, Outreach and Development
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Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002


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