Introduction to DHCP letter format and content guidance recently issued by FDA
10.7501/j.issn.1674-6376.2017.06.001
- VernacularTitle:FDA新发布的DHCP信函格式和内容指导原则介绍
- Author:
Huilai XIAO
- Keywords:
FDA: DHCP letter;
content;
format;
guidance
- From:
Drug Evaluation Research
2017;40(6):725-730
- CountryChina
- Language:Chinese
-
Abstract:
Dear Health Care Provider (DHCP) letters promptly are directed to doctors and other demanders by manufacturer or FDA to communicate change of description drug labeling,which are divided into three types-Important Drug Warning Letters,Important Prescribing Information Letters,and Important Correction of Drug Information Letters.FDA issued Guidance for Industry and FDA Staff Dear Health Care Provider Letters:Improving Communication of Important Safety Information in February 2017,described in detail the contents and format of the three letters;and listed the models.This paper introduces the main contents of the guidance.Call on China's pharmaceutical production enterprises and regulatory agency from the FDA experience establish the corresponding mechanism in line with China's national conditions,so that doctors and other demanders can be timely access to important new information of labeling to ensure clinical safe and effective medication.
