Newsletter - April 27, 2017
FDA’s Action-Inaction About Unapproved Drugs
This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. Read More
How Much Diversity is Required for FDA Approval?
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Read More
FDA’s Action-Inaction About Unapproved Drugs
This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. Read More
How Much Diversity is Required for FDA Approval?
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Read More
