Draft Guidances for Industry on Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format: General Considerations and for Food Additive and Color Additive Petitions; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format--General Considerations" and "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions." These documents are the first in a series of guidance documents intended to provide guidance for industry regarding the preparation of regulatory submissions in electronic format to the Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN). OFAS is providing these draft guidances as part of its implementation of 21 CFR part 11 and the Food Additives Regulatory Management (FARM) Project.