Artificial Intelligence in the Regulatory Processes –

Artificial intelligence can accelerate the drug development process and reduce its cost by virtual screening new molecules and optimizing patient recruitment in trials. 

Artificial intelligence can accelerate the drug development process and reduce its cost by virtual screening new molecules and optimizing patient recruitment in trials. 

According to the “Pharma Letter,” the FDA has supported using AI to:

  1. easy and quick access to approved drugs data for identifying potential drug repurposing strategies
  2. improve the quality and efficiency of the regulatory assessment for approving a new health technology  
  3. improve the consistency, quality, and efficiency of post-marketing safety and effectiveness monitoring

Now, does the FDA need to integrate giant tech companies into its existing group of stakeholders for this level of incorporation of AI in its processes or build an in-house tech division considering the security issues of the RWD and RWE used by the FDA for the decision-making?

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