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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.
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition ...
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [3] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It ...
To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, inviting comments; over 300 comments were received. On June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102–300) making minor changes.
Animal food manufacturers must implement current Good Manufacturing Practices and Preventive Controls.(Final rule published September 17, 2015) [22] Mandatory produce safety standards The FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables.
The US Food and Drug Administration is planning to propose a ban on certain hair-straightening products, such as chemical relaxers and pressing products, that have been linked to health risks.
These issues were made public in the hearings at the US Congress, which led to the FDA's publication of Proposed Regulations on GLP on November 19, 1976, [8] and establishment of the Final Rule in June 1979 [9] which became effective on June 20, 1979. [10] Proposed amendments were introduced on October 29, 1984. [11]
FDA Releases Final Rule for Unique Device Identification Final Rule Represents Significant Industry Shift to Use UDIs DELRAY BEACH, Fla.--(BUSINESS WIRE)-- Digital Angel Corporation ("Digital ...