Third-party certification guidance
This article was originally published in The Tan Sheet
FDA announces the availability of guidance for industry on third-party food safety certification programs in a Jan. 16 Federal Register notice. The guidance is a step toward the agency's "future recognition of one or more voluntary third-party certification programs for particular product types," FDA says. A draft version of the guidance published in July 2008 seemed to validate the decisions of some food and dietary supplement firms to seek certification for their facilities from industry trade groups (1"The Tan Sheet" July 14, 2008, p. 13)
You may also be interested in...
FDA's draft guidance on using third-party certification programs for food safety shows some dietary supplement companies are trendsetters.
CEO Werner Baumann admits he was skeptical at first as to whether the German group had the necessary know-how to manufacture vaccines but the firm's expertise in the development of biotech products has strengthened his belief Bayer can deliver.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.