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

FDA Launches Major Push for New Antimicrobials

The critical need for new medicines to combat infectious diseases that fail to respond to current medical treatment is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to suppor Powered by WPeMatico Continue reading FDA Launches Major Push for New Antimicrobials