Dec 1, 2014 | Drugs, Issue of the Month
By Charles “Chris” Celeste, Director of Regulatory Information and Submissions Two years have passed since passage of the Generic Drug User Fee Act (GDUFA). GDUFA is a significant law that introduced new requirements for active pharmaceutical ingredient (API)...
Dec 1, 2014 | Foods, FSMA Perspective
Senior Food and Drug Administration officials, including Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, traveled to Georgia, North Carolina, Florida, California and Vermont in recent weeks for “listening sessions” with stakeholders to...