FDA FCC CDC Blogs.docx - The Food and Drug Administration(FDA is a government agency under the executive branch It is responsible for regulating

FDA FCC CDC Blogs.docx - The Food and Drug...

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The Food and Drug Administration (FDA) is a government agency under the executive branch. It is responsible for regulating pharmaceuticals, biologics, medical devices, food products, cosmetics, tobacco products, and radioactive products. The agency's ultimate mission is public safety; it advances public health by implementing regulations requiring proof of safety, efficacy, and security of the products it oversees (). The FDA is currently headed by Acting Commissioner, Norman E. Sharpless, as of April 5, 2019. Prior to Dr. Sharpless, the administration was under the guidance of Commissioner Scott Gottlieb from May 2017. The FDA Commissioner is appointed by the president of the United States with advice and consent of the Senate. This governmental position does not have a specified term length, although recent commissioners tend to head the agency for an average of 2-4 years. Dr. Sharpless was appointed by president Donald Trump and has yet to be confirmed by the Senate (). One of the most notable responsibilities of the FDA is the regulation of various consumer products. Briefly, some of the items this agency regulates are: prescription drugs, dietary supplements, food additives, vaccines, cell and gene therapy products, allergenics, medical and dental devices, implants, prosthetics, microwave ovens, X-ray equipment, lasers, sunlamps, skin moisturizers, nail polish, personal care items, pet food, veterinary drugs and devices, and tobacco products. () While not currently up for comment, the FDA recently proposed a change to its human testing regulations by adding §50.22 to part 50 in November 2018 to align with the Cures Act. The proposed regulatory change was to allow the FDA to permit exceptions to the requirement of informed consent during human clinical testing in low-risk trials. In short, current regulation requires informed consent for any human testing of investigational therapeutics including drugs or medical devices, unless it is otherwise impossible to obtain that consent (due to specifically set guidelines) and great harm would come to the human subject if they did not receive the investigational therapeutic. The current regulation does
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not provide any exception for low-risk investigations. The Common Rule was set up after the Cures Act, which did allow for some exceptions; however, at the time the Common Rule was implemented by the Department of Health and Human Services (the parent agency of the FDA), the FDA did not adopt the exception to informed consent in low- risk trials due to not having the authority to do so (53 FR 45671 at 45679). However, in 2014, it was recommended by the advisory committee on Human Research Protections that the Common Rule standard allowing for waiving informed consent on minimal-risk trials would be appropriate for the FDA to adopt and would assist FDA- regulated clinical trials. Therefore, in November 2018, the FDA proposed
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