FDA Wants Your Perspective on Clinical Trial Demographic Data
By: Jonca Bull, M.D. When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances,...
View ArticleFDA’s multi-pronged approach helps meet the challenge of bringing new and...
By: Edward M. Cox, MD, MPH With a growing number of infections becoming increasingly resistant to our current arsenal of antibiotics, developing new antibiotics to treat serious or life-threatening...
View ArticleClinical Trials: Enhancing Data Quality, Encouraging Participation and...
By: Margaret A. Hamburg, M.D. Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient...
View ArticleIn India, With Our Sleeves Rolled Up
By: Howard Sklamberg and Michael Taylor Howard Sklamberg These facts surprise many people, but roughly 80 percent of active pharmaceutical ingredients, 40 percent of finished drugs, 80 percent of...
View ArticleFDA Reaches Out to Minorities During Hepatitis Awareness Month
By: Jovonni R. Spinner, M.P.H., C.H.E.S Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in...
View ArticleFDA and NIH Release a Draft Clinical Trial Protocol Template for Public Comment
By: Peter Marks, M.D., Ph.D. Enhancing important efforts around clinical trials continues to be a key scientific priority. Another way we can encourage clinical trials is to look for ways to help...
View ArticleThe Rise in Orphan Drug Designations: Meeting the Growing Demand
By: Gayatri Rao, M.D., J.D. Developing drugs for rare diseases, once considered a rare phenomenon itself, has fast become a mainstay for many companies’ drug development pipelines. This is exciting...
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