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)...
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...
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...