What Challenges are Associated with Pre Market Approval?
Several challenges can arise during the pre market approval process:
Data Variability: Differences in study designs and methodologies can lead to variability in results, complicating the evaluation process. Ethical Considerations: The use of animal testing raises ethical concerns, prompting the need for alternative testing methods. Regulatory Harmonization: Differences in regulatory requirements across countries can create barriers for global product approval. Cost and Time: The extensive testing and data submission process can be costly and time-consuming for companies.
