What Are the Steps Involved in Regulatory Approval?
The regulatory approval process typically involves several steps:
Preclinical Testing: Initial testing on animals or in vitro systems to evaluate toxicity. Clinical Trials: Testing in human subjects to assess efficacy and safety. Submission of Data: Compiling and submitting data to regulatory bodies for review. Review and Approval: Regulatory agencies review the data and issue approval or request further information.
This process ensures that any potential adverse effects are identified before a product reaches the market.