Government Shutdown to Have Repercussions for Months to Come

The longest government closure in history created havoc in Washington and beyond, creating months of work for agencies to regain efficient operations. Despite extensive user fee funding for FDA regulatory programs for drugs, biologics and medical devices, many agency programs were halted or put Powered by WPeMatico Continue reading Government Shutdown to Have Repercussions for Months to Come

Drug Research and Review Issues on Radar at FDA

It will be a challenge for FDA to match or exceed its success this past year in approving record numbers of innovative and generic drugs. These achievements reflect the ability of biopharma companies to capitalize on important advances in science, as well as strong support from the regulators in Powered by WPeMatico Continue reading Drug Research and Review Issues on Radar at FDA

FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be

Paul Glimcher In a sign of the increasing role real-world evidence (RWE) will have in healthcare research, FDA recently announced a $100 million proposal to build a modern system to gather RWE from about 10 million individuals. The good news is that this could transform clinical trials Powered by WPeMatico Continue reading FDA’s $100 Million Real-World Evidence Project: Making It All It Can Be