Oct 30, 2018· Comment from Animal Health Institute (AHI)· FDA-2009-D-0052-0015
The ANIMAL HEALTH INSTITUTE (AHI) appreciates the opportunity to comment on the Draft Guidance for Industry: Documenting Electronic Data Files and Statistical Analysis Programs. AHI values CVMs commitment to develop efficient ways to electronically submit data and thanks CVM for providing a draft of their current thinking through the guidance. Upon reading the guidance, AHI members generated additional questions and recommendations for consideration. Formal comments are attached.