Remix education

Regulatory aspects of pharmaceuticals with focus on us market

Father of American pharmacy is William Procter


In 1930 US Food and Drug Administration was established as a statutory agency under the US Department of Health and Human Welfare. Today there are more than 11500 employees, 223 plus offices, 13 plus labs across the US and more than six countries including INDIA.

Mission of US Food and Drug Administration is to protect and promote public health. Jurisdiction of it includes, food products, vaccines, blood and biologicals , medical devices, radiation, veternary products and cosmetics.

US Food And Drug Administration do not govern alcoholic beverages , general consumers products like candies, cholcolates, pesticides, common groceries.

Organizational structure is department wise and functional, headed by a commissioner who reports to secretary of Health and Human Services.

Two major areas of responsibility of US Food And Drug Administration are regulation of drug product approvals and compliance.

Other areas are training, Rand D, Alerts, Recalls , Guidance for industry , public awareness, imports and exports of medicines.

Headquarter of US Food And Drug Administartion is located in silver spring, maryland, USA .

FDA opened first foreign office in 2008