In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more
9/12/2017
/ Beverage Manufacturers ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Reauthorization Act ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Information Requests ,
Inspections ,
Medical Devices ,
Office of Regulatory Affairs (ORA) ,
Prescription Drugs
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more