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  5. Review Team Responsibilities
  1. Center for Drug Evaluation and Research | CDER

Review Team Responsibilities

The review teams analyze new drug applications (NDAs) and biologic licensing applications (BLAs). During drug development, the teams also review Investigational New Drug Applications (INDs). Each team member uses their expertise to answer these key questions:

  • Is it reasonably safe to study an investigational drug in humans and will proposed studies provide data needed to show safety and efficacy?
  • Is the drug safe and effective in its proposed use and do the benefits of the drug outweigh the risks?
  • Is the proposed labeling appropriate and if not what should it contain?
  • Are the methods used in manufacturing the drug and the controls adequate?

Review teams consist of these members

  • Project Manager - Project managers are the primary contact with the sponsor. They coordinate the activities of the review team throughout the review process. They:
    • prepare the review plan with the team
    • monitor the status of review activities
    • maintain up-to-date information on milestones
    • facilitate actions to solve problems
    • assure that the review is completed on schedule
       
  • Medical Officer - Medical officers review all clinical studies. They:
    • evaluate and advise on protocol design, endpoints, and analysis for drug approval
    • evaluate the clinical investigators who supply the clinical data
    • review the clinical investigation
    • describe and analyze each clinical pharmacology study
    • describe and analyze controlled and uncontrolled studies
    • review other relevant safety and efficacy data
     
  • Pharmacology/Toxicology Specialist - These team members review all nonclinical (animal) studies including:
    • pharmacological action of the drug as related to its intended clinical use
    • potential toxic effects of the drug as related to its intended use
    • reproductive and /or fetal effects
       
  • Statistician - These team members:
    • provide conclusions on safety and efficacy study data
    • study the protocols
    • review the statistical analysis plan
    • compare conduct of the studies against protocol and analysis plans
    • conduct analyses of safety and efficacy data
       
  • Clinical Pharmacology/Biopharmaceutics - These team members:
    • evaluate pilot and background ADME studies (adsorption, distribution, metabolism, and elimination)
    • evaluate bioavailability and bioequivalence studies
    • evaluate pharmacokinetic studies
    • evaluate in vivo studies using pharmacological or clinical endpoints
    • evaluate in vitro (laboratory) studies that define the release rate of the drug substance from the dosage form
       
  • Chemists/Biologists/Microbiologists - These reviewers evaluate the drug substance/drug product in these areas:
    • components and composition
    • manufacturing and controls
    • batch formulation and records
    • description of facilities
    • specifications and tests
    • stability profile
    • environmental impact analysis report

The following groups may also be consulted during the review process:

More information on the new drug application process.

 
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