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Food and Drug Administration

Food and Drug Administration

What is Food and Drug Administration

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services.

Food and Drug Administration
Food and Drug Administration

When and why was FDA formed

Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. Federal public health protection was vigorously advocated by Harvey Washington Wiley, who at the time was chief chemist of the Bureau of Chemistry of the U.S. Department of Agriculture, FDA’s predecessor.

Food and Drug Administration Review

FDA Review In assessing an NDA, the FDA undertakes its closest scrutiny of all during the drug approval process. Its principal goal during review is to determine whether the benefits of the new drug outweigh the risks. If the FDA approves the drug, the sponsor may begin manufacturing and marketing the drug immediately. The FDA does not stop monitoring a drug once it has been marketed. It continues to evaluate the drug’s safety and effectiveness through its program of postmarket surveillance.

An Analysis of the Food and Drug Administration Database

The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality is not based on research data. We assessed suicides, suicide attempts, and depressive symptom reduction in studies of 7 new antidepressants using the Food and Drug Administration database.

FDA approves new kind of lymphoma treatment

The Food and Drug Administration approved rituximab (Rituxan) for treating patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. The drug has not yet been tested in persons with HIV, although trials are now being organized. Rituximab, given in four doses over a 22-day period, works by killing B-cells, and appears to work well in combination with standard chemotherapy.

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