Apr 1, 2014 | Foods, FSMA Perspective
FDA announced the release of new draft guidance on requirements for prior notice of imported food, in a March 31 Federal Register notice. Some of the draft guidance responds to provisions in section 304 of the Food Safety Modernization Act (FSMA). The new draft...
Apr 1, 2014 | Issue of the Month, Medical Devices
By EAS Director of Regulatory Affairs and Submissions, Chris Celeste Since December 1978, medical device manufacturers have been subject to FDA regulations and inspections based on the Good Manufacturing Practices (GMP) requirements. On June 1, 1997 FDA amended the...