Food and Drug Administration Regulation of in Vitro Diagnostic Devices

Food and Drug Administration regulation of food safety.

Food and Drug Administration regulation and evaluation of vaccines.

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the qual...

Food and Drug Administration regulation of tobacco products: introduction.

T his past July, the US Senate voted 78 to 15 to grant the Food and Drug Administration (FDA) authority to regulate tobacco products. The proposed, precedent setting legislation is part of a larger tax bill and is also tied to a controversial tobacco growers’ buyout. In order to become law, the Senate version of the Bill, sponsored by Republican Senator Mike DeWine of Ohio and Democrat Edward K...

Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration

ASH represents more than 15,000 hematologists who are committed to the treatment of blood and blood-related diseases. These diseases include anemias (such as sickle cell disease and thalassemia), thrombosis and bleeding disorders, as well as malignant hematologic disorders such as leukemia, lymphoma, and myeloma. ASH members include clinicians who order Next Generation Sequencing (NGS) diagnost...

An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.

The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the age...