Difference Between CBER and CDER

𝗖𝗕𝗘𝗥 (𝗖𝗲𝗻𝘁𝗲𝗿 𝗳𝗼𝗿 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵)

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝘆: CBER regulates biological products, which are complex substances derived from living organisms or their byproducts. These products include vaccines, blood products, gene therapies, tissues, and medical devices that contain biological components.

𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗰𝗲𝘀𝘀: CBER reviews applications for Biologics License Applications (BLAs) to ensure the safety, efficacy, and quality of biological products. The BLA review process is more complex than the New Drug Application (NDA) review process due to the inherent variability of biological products.

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲: CBER has expertise in the following areas:

  • Allergy, clinical immunology, and rheumatology
  • Infectious diseases
  • Hematology and coagulation
  • Oncology

𝗖𝗗𝗘𝗥 (𝗖𝗲𝗻𝘁𝗲𝗿 𝗳𝗼𝗿 𝗗𝗿𝘂𝗴 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵)

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝘆: CDER regulates human drugs, which are chemical substances manufactured for therapeutic or diagnostic purposes. These products include small molecule drugs, large molecule drugs, and combination products.

𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗰𝗲𝘀𝘀: CDER reviews applications for NDAs to ensure the safety, efficacy, and quality of human drugs. The NDA review process is generally more standardized and less complex than the BLA review process.

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲: CDER has expertise in a wide range of clinical areas, including:

  • Cardiovascular disease
  • Oncology
  • Neurology
  • Psychiatry
  • Infectious diseases

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Resource Person: Amit Singh

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