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The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate. [1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority ...
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
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Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals ...
The authorization to expand Covid-19 booster shot eligibility was met with support from experts. But some questioned why the Food and Drug Administration didn’t make the move sooner.
One result of the passing of the act was a reduction in the time for the approval of new pharmaceutical drugs. [4] Critics questioned whether the shortened time frame for the approval of prescription drugs would do more harm than good. [5] In 2022, the Act was updated with the FDA Modernization Act 2.0.
The FDA has removed the drug from its shortage list and set a timeline for pharmacies to stop making compounded versions of the drug — meaning the only version available will be the FDA-approved ...