I spent 20 years in pharma in medical affairs and clinical development, and this use case example raises so many important issues in the current regulatory pathway to drug approval. If nothing else FDA should turn it's focus to real world evidence/data instead of it's reliance on current traditional clinical trials.
I spent 20 years in pharma in medical affairs and clinical development, and this use case example raises so many important issues in the current regulatory pathway to drug approval. If nothing else FDA should turn it's focus to real world evidence/data instead of it's reliance on current traditional clinical trials.
I feel very seen!