Re-Examination

Re-examination, in the context of regulatory processes for drug evaluation and approval, refers to a review process that allows for reconsideration or reassessment of a previously made decision by a regulatory authority. It provides an opportunity for the applicant or sponsor of a drug application to challenge or address issues raised by the regulatory authority during the initial evaluation.

The need for re-examination may arise when the applicant disagrees with the regulatory decision, believes that additional data or information can address concerns raised by the authority, or identifies procedural errors or inconsistencies in the initial evaluation.