TAG:

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.

FDA Says 8 of 11 Tests Fail in Serology Test Review

This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…

Read More



COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail

CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from…

Read More



Questions Arise as FDA Assesses Serology Tests

CEO SUMMARY: On June 4, the FDA released results of an evaluation of some of the 20 tests offered for sale in this country to identify antibodies for SARS-CoV-2. A quality control expert in clinical labs called the antibody test analysis deeply flawed in part because of the study’s …

Read More



Chicago Lab Launches LDT, Finds 20% Positive

CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…

Read More



Regulators Acted Slowly as Labs Developed Tests for Coronavirus

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since…

Read More



Providers Get Creative as FDA Clears More IVD Firms’ Tests

CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for …

Read More



2008’s Top Ten Lab Stories Lacked Disruptive Impact

CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…

Read More



GE, UPMC Create Company for Digital Path Imaging

CEO SUMMARY: It’s a new joint venture with the potential to transform surgical pathology. General Electric Healthcare has extensive experience at supporting physicians’ work flow with digitized imaging systems, plus ample experience with molecular bio-markers. The University of Pittsb…

Read More



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…

Read More



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 …

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.