The United States Food and Drug Administration (FDA) released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases, Outsourcing-Pharma.com reports. FDA collaborated with the European...
The U.S. Food and Drug Administration (FDA) issued a draft guidance suggesting the agency adopt an International Council for Harmonization (ICH) to a 1998 clinical trials statistics guideline. The original ICH guideline (ICH E9) focused on the use of sensitivity...
The US FDA released draft guidance this week on the “problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials,” Zachary Brennan of RAPS reports. The FDA...
After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...
Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...