What is the U.S. Food and Drug Administration’s (FDA) regulatory role in ensuring quality?
As the industry’s regulating body, FDA is charged with performing inspections of foreign and domestic companies that manufacture pharmaceutical ingredients and excipients as well as the manufacturers of the final products. These audits are a means for an outside source to verify GMP compliance and quality. Additionally, FDA has a range of enforcement tools to ensure compliance. All drug establishments, both domestic and foreign, must register with FDA if they have drugs in U.S. commerce. Drug establishments must list their drugs and provide national drug code numbers and registration numbers of other establishments within the parent company where the drug was manufactured or processed. Manufacturers are required to update these lists twice a year.
Related Questions
- When did the U.S. Food & Drug Administration (FDA) require that pancreatic enzyme products (PEPs) receive formal FDA-approval?
- Why does the U.S. Food & Drug Administration (FDA) make it difficult to get B17 and Laetrile (and the real facts about them)?
- Are TomoTherapy Incorporated’s products cleared by the U.S. Food & Drug Adminstration (FDA) and other regulatory agencies?
