In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes […]
John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]
In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events. In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached. We can stream tv shows, live […]
