May 1, 2014 | Foods, FSMA Perspective
In 1990, Congress enacted the Sanitary Food Transportation Act that directed the Department of Transportation to promulgate regulations for the transportation of food to ensure its safety. DOT issued a proposed rule in 1993, but later determined that it lacked...
May 1, 2014 | Foods, FSMA Perspective
FDA offers some insights into its strategy for implementing the next phase of the Food Safety Modernization Act (FSMA) in a guidance document posted on the agency’s website May 2. A key element of the agency’s operational strategy will be to rely heavily on the...
May 1, 2014 | Drugs, Issue of the Month
By Charles “Chris” Celeste, Director of Regulatory Information and Submissions FDA expects industry to begin submitting higher-quality applications to facilitate expedited reviews and approvals of generic drugs, agency officials explained at the Generic Drug User Fee...