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FDA Approval Process
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
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FDA Approval Process
[/vc_column_text][vc_column_text]The United States Food and Drug Administration originated from a fraction of the United States Department of Agriculture (USDA). From the Patent Office to one of the most outstanding consumer protection organisations in the world. It aims to ensure that innovative medical therapies reach the general population as rapidly as possible while also guarantee that they are safe and effective. In the face of pressing consumer needs, the FDA has been chastised for its slow and costly processes and the fact that the time it takes to release a new medicine in the United States is substantially longer than in other Western countries. From pre-clinical testing through approval, new drugs and devices in the United States require an average of 12 and 7 years, respectively. Medical device development costs millions of dollars, and recent research estimates that the total cost of a new medication is more than $1 billion. FDA protocols may be difficult for researchers seeking clearance for novel medicines and devices. This sequence aims to provide you with an overview of the stages of getting new drugs and devices approved by the FDA. It begins with the approval of new medicines and continues with the support of medical devices.
All new drug development follows the same path: basic research leads to drug conception, pre-clinical development and drug prototype creation. The FDA must be consulted when a substance is ready for clinical testing before human subjects are tested. An accepted IND application grants a researcher a technical exception from this federal law, allowing clinical investigators to deliver medication to various study locations across the country.[/vc_column_text][vc_column_text]
References
Van Norman, Gail A. “Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs.” JACC: Basic to Translational Science 1.3 (2016): 170-179.
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