Formed in 1906, the Food and Drug Administration (FDA) of the United States is an organization devoted to the promotion and protection of the public health. Part of the United States Department of Health and Human Services, the FDA works to regulate and supervise the production of various food, tobacco, and drug products. The Food and Drug Administration’s oversight also extends to medical devices, vaccines, dietary supplements, and veterinary products. In addition, the FDA enforces various laws as they pertain to such products, specifically portions of the Public Health Service Act and related legislation. These regulations encompass everything from food and drug regulation to interstate travel sanitation and review of products used for assisted reproduction.
In terms of regulatory programs, the Food and Drug Administration oversees nearly every aspect of testing, manufacturing, and labeling of drugs and food. With respect to drugs specifically, the FDA also regulates marketing, safety, and efficacy. For example, pharmaceutical companies may only advertise a drug for the specific purpose(s) for which it has been approved. Various other stipulations associated with generic drugs and over-the-counter drugs also exist.
Today, the FDA continues to modernize and re-define its regulations and responsibilities. As of March 2004, the organization implemented the Critical Path Initiative, which worked to modernize scientific advances in evaluation and manufacturing techniques. Testing requirements for pediatric drugs have also become more heavily enforced, as have the rules involving drugs used for the treatment of autoimmune diseases and cancer.
About the Author:
A highly experienced pharmaceutical industry professional, Stephen Corba serves the Investigational Drug Delivery Program as the President of Sales. His current responsibilities revolve around medical products and clinical studies. In past years, Stephen Corba worked with Avenel Surgical & Pharmaceuticals as the Vice President of Sales and Regional Account Executive.
Stephen Corba 