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首页> 外文期刊>Washington Drug Letter >OCP MaPP Requires Briefings On Some Pediatric Supplements
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OCP MaPP Requires Briefings On Some Pediatric Supplements

机译：OCP MaPP要求简报一些儿科补品

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摘要

Drugmakers that submit pediatric supplement NDAs with potentially complicated or controversial clinical pharmacology or biophar-maceutical issues should be aware that CDER's Office of Clinical Pharmacology (OCP) is now required to hold briefings on them, according to a revised Manual of Policies and Procedures (MaPP).rnMost of the changes from the previous 1997 version are relatively minor, OCP Director Lawrence Lesko told WDL. He said the requirement to hold an office-level OCP briefing for complicated or controversial pediatric supplement NDAs was made "because we wanted to use this as an opportunity to review the quality of submissions and the quantity of pediatric information in the submissions." The revision posted to the CDER website this week has already taken effect.
机译：根据修订后的政策和程序手册（MaPP），提交具有潜在复杂或有争议的临床药理学或生物噬菌体问题的小儿补品NDA的药品制造商应注意，CDER的临床药理学办公室（OCP）现在必须对其进行简介。 OCP主任Lawrence Lesko告诉WDL，与1997年以前的版本相比，大多数更改都相对较小。他说，要求对复杂或有争议的儿科补充NDA举行办公室级OCP简报是因为“我们希望以此为契机，审查提交的质量和提交的儿科信息的数量。”该修订本周发布到CDER网站上已经生效。

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