FDA's requirements for clinical pharmacology section of prescription drug labeling
10.7501/j.issn.1674-6376.2017.04.003
- VernacularTitle:FDA对处方药说明书临床药理学项目的要求
- Author:
Huilai XIAO
- Keywords:
FDA;
prescription drug labeling;
clinical pharmacology section;
guidance
- From:
Drug Evaluation Research
2017;40(4):442-449
- CountryChina
- Language:Chinese
-
Abstract:
FDA issued the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (final guidance)in December 2016.The Guidance stipulated that clinical pharmacology section must contain three subsections—echanism of action,pharmacodynamics,and pharmacokinetics;If necessary,it can be added to microbiology and pharmacogenomics subsections etc.,as well as explained that the contents of each subsection should be included,also discussed the writing general principles and the format of the section.This paper introduces the main contents of the guidance,with the hope of helping writing and supervision on our country labeling.
