EPISODE · Oct 13, 2025 · 0 MIN
Is Clinical Research Ready for the new FDA?
from DarshanTalks Podcast · host Darshan Kulkarni
Send us Fan MailThe FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potential upticks in physician enforcement. While this use of AI in research compliance hasn’t fully emerged yet, AI is already being applied in promotion oversight and will likely accelerate compliance monitoring. Industry now needs to identify and tighten key processes to stay ahead as AI scales enforcement.Support the showwww.kulkarnilawfirm.com
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Is Clinical Research Ready for the new FDA?
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