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Intercenter Agreement Between the Center for Drug Evaluation and

Intercenter Agreement Between the Center for Drug Evaluation and 2025

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The document is a medical review for the New Drug Application (NDA) 203,188 submitted by Vertex Pharmaceuticals for VX-770 (ivacaftor), a CFTR potentiator intended for the treatment of cystic fibrosis (CF) in patients aged 6 years and older with a G551D mutation. The review summarizes the clinical development program, including efficacy and safety data from multiple studies, highlighting significant improvements in lung function and weight gain among treated patients compared to placebo. It also discusses potential safety concerns, including liver enzyme elevations and drug interactions, while concluding that the benefits of VX-770 outweigh its risks for the indicated population.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the difference between CBER and CDER?

CBER focuses on a broad range of biologics, ensuring their safety and effectiveness, whereas CDER tends to focus on therapeutic proteins and other drug products. Their collaborative efforts are essential in protecting public health and advancing innovation in medical treatments.

What does CBER regulate?

Thats where scheduled meetings with FDAs Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) come in.

What is the full form of CDER and CBER?

Although most biologics are regulated by the Center for Biologics Evaluation and Research (CBER), monoclonal antibodies, therapeutic proteins, and immunomodulators fall under CDERs regulatory oversight.

What is the difference between CBER and CDRH?

The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

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