Uk.reuters.com just released an article about the lackluster number of approved drugs by FDA in 2013. In 2013 only 27 were approved vs. 39 in 2012, which was the most since 1997. FDA attributed the large decrease to fewer applications in 2013 which was down from 41 to...
David David Pittman from medpagetoday.com has written an article on FDA’s push to include sicker patients in clinical trials. In the article David brings up the new internal memo that requests drug reviewers to push for a broader population in trials. By doing this it...
Yevgeniy Feyman of Forbes has written an intriguing article entitled “Shocking Secrets of FDA Clinical Trials Revealed” the costs of bringing a new drug to market. Feyman shares that “according to Joseph Dimasi of the Tufts Center for the Study of Drug Development,...
We are looking for a new talent to join the Pearl team. Effective immediately, Pearl Pathways in Indianapolis, Indiana has a new position open for a Regulatory Publication Coordinator. Please see the job description online here. Experience with eCTD for an NDA or...
The final FDA guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011. FDA encourages risk based remote monitoring,...
