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This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND)
These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design,...
This document provides guidance to industry and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on good review management principles and practices (GRMPs) for the conduct of the first cycle
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications. Guidance for Industry and Review Staff. Good Review Practice. Additional...
This good review practice (GRP) guidance is intended to assist reviewers conducting the clinical safety reviews as part of the NDA and BLA review process, provide standardization and consistency in the format and content of safety reviews, and ensure that critical presentations and
A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool. Below are example worksheets that define the minimal/ideal profile of the final marketed product and shows the ultimate goals of the proposed therapy ...
Purpose of an NDA. Enables FDA to determine: Whether the drug is safe and effective for the proposed indication, and whether the drug’s benefits outweigh the risks. Whether the drug’s proposed labeling is appropriate, and what should be included in the package insert.
