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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 ...
Faced with the opioid epidemic, which had become a public health crisis by 2017, the FDA requested Endo Pharmaceuticals to remove oxymorphone hydrochloride from the market. It was the first time in FDA history, that the FDA had "taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of ...
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
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 ...
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Exterior of the Pfizer World headquarters building. Pfizer produced the first COVID-19 vaccine to gain emergency use authorization. Sam Aronov/Pacific Press/LightRocket via Getty ImagesThe Food ...
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.
In July 2013, the FDA issued a boxed warning for the antimalarial drug mefloquine, noting the drug's adverse neuropsychiatric side effects, and emphasizing neurological effects from the drug could "occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent". [23]