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Food and Drug Administration (FDA)
The Food and Drug Administration (FDA or USFDA) 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 responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been “adulterated.”
The responsibility for examining food and drugs for such “adulteration” or “misbranding” was given to the USDA Bureau of Chemistry. In 1927, the Bureau of Chemistry’s regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
The FDA is most popularly known for its work in regulating the development of new drugs. Its powers related to clinical laboratories include the Clinical Laboratory Improvement Amendments (CLIA) that regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
The agency also has the authority to issue pre-market clearance of laboratory-developed tests (LDTs) for in vitro diagnostic instrument systems and IVD test kits that a laboratory wishes to sell to other labs. More recently, FDA has decided to launch the regulation of all LDTs, including pre-market review for higher-risk LDTs.
Digitization of Pathology Is Making Steady Progress
CEO SUMMARY: Pathology digitization incorporates a greater scope of work-changing technologies than telepathology. It incorporates information technology, new diagnostic knowledge, and other engineering innovations to help pathologists move past glass and paper. Existing digital pathology…
FDA Sends Warning Letter to Abbott Laboratories
CEO SUMMARY: On March 13, 2007, the Food and Drug Administration sent a warning letter to Abbott Laboratories’ Chairman and CEO, Miles D. White. The letter identified nine quality system violations and requested a satisfactory response by August 15, 2007. The warning letter is based on …
“March 15, 2004 Intelligence: Late Breaking Lab News”
Bar codes will soon be an essential element in most laboratories. Final regulations published on February 26 by the Food and Drug Administration (FDA) will take effect during the next two years. The FDA is requiring that prescription and over-the-counter drugs given to hospital patients have bar code…
Roche, Digene, Centrex, Labtest.com, Specialty Labs, Tripath Imaging
ROCHE DIAGNOSTICS POSITIONED TO SERVE PUBLIC HEALTH LABS HEIGHTENED CONCERNS over bioterrorist attacks have accelerated plans within the public health lab sector to acquire state-of-the art diagnostic technology in DNA typing and enzyme immunoassay. Roche Diagnostics has in…
AccuMed, AutoCyte, Cytyc, MorphoMetrix, Neuromedical, NeoPath
Automated Cytology Update As predicted by THE DARK REPORT, the field of automated cytology has become a boiling pot, filled with controversy and change. Profits are meager. As we expected, the major issue revolves around the cost of this enhanced technology versus the measurable…
AutoPap System Cleared For Primary Screening
CEO SUMMARY: It is time for pathologists and cytologists to buckle their safety belts. The marketplace for automated cytology is entering a new cycle of rapid change. NeoPath’s AutoPap System is now poised to demonstrate that it is economical and clinically viable. Expect continual impr…
Neuromedical’s PAPNET® Undergoing Enhancement
CEO SUMMARY: Financial pressures and a falling stock price impelled Neuromedical Systems, Inc. to revamp its sales and marketing plan for the PAPNET® System. During 1998, expect a new sales approach that supports a product with enhanced capabilities. Neuromedical is developing overseas m…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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