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Home » FDA Finalizes Guidance on Preparing Effectiveness Summaries in NDAs, BLAs
FDA Finalizes Guidance on Preparing Effectiveness Summaries in NDAs, BLAs
Drugmakers submitting NDAs and BLAs should prepare a comprehensive analysis of all clinical trial data that describes the therapy’s effectiveness, strengths and weaknesses and highlights missing information, such as pharmacokinetic or pharmacodynamic studies, the FDA says.