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

States Expand Transparency & Disclosure Requirements

Just as biopharma companies are mastering the complexities of the five-year-old federal Open Payments program, state governments are enacting a host of additional marketing and disclosure rules and restrictions on industry interactions with health care professionals (HCPs). This stepped-up actio Powered by WPeMatico Continue reading States Expand Transparency & Disclosure Requirements