Go offline with the Player FM app!
Is Clinical Research Ready for the new FDA?
Manage episode 513368126 series 3506216
The 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.
288 episodes
Manage episode 513368126 series 3506216
The 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.
288 episodes
All episodes
×Welcome to Player FM!
Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.