Newsletter - September 23, 2021
FDA’s Publication Highlights How to Use/Not Use Precedent Information
In almost 2 out of 5 cases where the efficacy data submitted in support of a market approval application was borderline (i.e., not clearly conclusive), FDA used its discretion to approve products, citing no clear public reasoning for its decision. Many times, it was done differently than FDA’s own previous decisions...Read More
Paying Participants Helps with Recruitment for Low-Risk but Not The High-Risk Clinical Trials
An old ethical question about should a sponsor pay or not pay subjects for participating in their clinical trials was investigated in two clinical trials, one with high risk to subjects and another with low risk to subjects. It was found that for the study where subjects would have low risk to participate, the financial...Read More
FDA’s Publication Highlights How to Use/Not Use Precedent Information
In almost 2 out of 5 cases where the efficacy data submitted in support of a market approval application was borderline (i.e., not clearly conclusive), FDA used its discretion to approve products, citing no clear public reasoning for its decision. Many times, it was done differently than FDA’s own previous decisions...Read More
Paying Participants Helps with Recruitment for Low-Risk but Not The High-Risk Clinical Trials
An old ethical question about should a sponsor pay or not pay subjects for participating in their clinical trials was investigated in two clinical trials, one with high risk to subjects and another with low risk to subjects. It was found that for the study where subjects would have low risk to participate, the financial...Read More
