Electrophysiology devices and the regulatory approval process within the U.S. FDA and abroad
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DOI: 10.1007/s10840-019-00607-x
Abstract: Almost all electrophysiology (EP) devices need to obtain premarket approval before they can be commercially sold and available for use in the community. The US Food and Drug Administration (FDA) has different paths to market… read more here.
Keywords: regulatory approval; approval process; devices regulatory; electrophysiology devices ... See more keywords
Development of Vaccines for Australia: TGA Regulations and Approval process
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DOI: 10.52711/0974-360x.2023.00245
Abstract: Since Edward Jenner’s creation of vaccine 200 years ago, which been serving as a boon to mankind till today and being benefited by vaccination. Childhood vaccination is done for infectious disease like Polio, measles, rubella… read more here.
Keywords: vaccines australia; approval; approval process; process ... See more keywords
Regulatory Approval Process for Drugs in Canada-A Challenging Task
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DOI: 10.5958/0974-360x.2019.00538.9
Abstract: The drugs and medical devices for human use in Canada are regulated by Health Canada’s Therapeutic Products Directorate (TPD). Health Canada is responsible to implement the rules and regulations for the marketing of drugs. Health… read more here.
Keywords: canada; approval process; drugs canada; drug ... See more keywords