Regulatory Issues
“Regulatory bodies such as the Federal Drug Administration (FDA) already have a full plate. In the US, FDA-regulated products account for 20 percent of each dollar spent by American consumers each year. More specifically, the work of the regulatory authorities include the following:
- Carefully considering benefits and risks when evaluating medical products
- Staying on top of rapidly advancing scientific innovations
- Providing industry guidance to encourage the development of new therapies in promising areas
- Ensuring the appropriate usage of the most recent science and technology in appropriate ways
- Advising in clinical trial design, drug and device development and clinical practice
- Coordinating the dialog between key constituents such as scientists, government agencies, standards organizations and clinicians to evaluate new diagnostics and therapeutics”
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