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FDA (2021) Best Practices for Communication between FDA and IND Sponsors during Drug Development.
https://www.accessdata.fda.gov/cder/ind_sponsors/ind_scripts/index.htm,2021-10-20

has been cited by the following article:

• TITLE: Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China

  AUTHORS: Yanjiao Zhao, Ling Li, Xinxin Wang, Yongfa Chen

  KEYWORDS: Drug Registration, Compliance Management, Compliance Program, Pharmaceutical Manufacturers

  JOURNAL NAME: Pharmacology & Pharmacy, Vol.12 No.12, December 28, 2021

  ABSTRACT: In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management forU.S. pharmaceutical manufacturers as described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug registration stages. Finally, some suggestions and implications are proposed to strengthen the construction of compliance management for Chinese drug registration applicants based on the former practical experience.