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(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them.
The American Clinical Laboratory Association said Monday it “has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests ...
On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules — dubbed the Food Traceability Final Rule — will go into effect. The rule, the FDA explained, "establishes ...
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
The American Cancer Society has applauded the FDA’s new rule, saying it will reduce delays in diagnosis. It’s estimated that about 1 in 8 women will develop breast cancer in her lifetime.