Follow
Balanced: A good review is objective and unbiased.
Considers context: A good review considers the data and the conclusions of the applicant in the context of the proposed conditions of use and storage, and may include perspectives from patients, health-care professionals and other RAs’ analyses and decisions.
Evidence-based: A good review is evidence-based and reflects both the scientific and regulatory state of the art. It integrates legislative, regulatory and policy frameworks with emerging science.
Identifies signals: A good review comprehensively highlights potential areas of concern identified by the applicant and the reviewers.
Investigates and solves problems: A good review provides both the applicant’s and the reviewers’ in-depth analyses and findings of key scientific data and uses problem-solving, regulatory flexibility, risk-based analyses and synthesis skills to devise and recommend solutions and alternatives where needed.
Makes linkages: A good review provides integrated analysis across all aspects of the application: preclinical; nonclinical; clinical; chemistry/biocompatibility; manufacturing; and risk management plan. It includes timely communication and consultation with applicants, internal stakeholders and, as needed, with external stakeholders who have expertise relevant to the various aspects of the application.
Thorough: A good review reflects adequate follow-through of all the issues by the reviewers.
Utilizes critical analyses : A good review assesses the scientific integrity, relevance and completeness of the data and proposed labelling, as well as the interpretation thereof, presented in the application.
Well-documented : A good review provides a well-written and thorough report of the evidence-based findings and conclusions provided by the applicant in the dossier, and the reviewers’ assessment of the conclusions and rationale for reaching a decision. It contains clear, succinct recommendations that can stand up to scrutiny by all the parties involved and could be leveraged by others.
Well-managed : A good review applies project and quality management processes, including clearly defined steps with specific activities and targets.
