Could Enrichment Cloud CV Signal For Weight-Loss Drugs?
FDA’s Robert Temple says the trend in risk indicators is the important element when interpreting data from high-risk patients for low-risk patients, after some advisory panel members question the relevance of data from older, sicker participants to the younger patients who take obesity products.
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Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs
Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.
FDA Diabetes Guidance Encourages Enrollment Of Sicker Patients
In raising pre-market safety standards, FDA says that development time will not necessarily increase if a robust protocol is used.
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Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.