Michael McCaughan
Latest From Michael McCaughan
US FDA Drug Center ‘Snapshots’ Show Progress, But Are They Measuring The Right Thing?
US FDA trial enrollment data show improving enrollment across broad demographic definitions, but stakeholders agree more attention is needed for complex subgroups. Could larger trials be part of the answer?
Clinical Trial Diversity: US FDA’s Califf Calls For Global Focus
Commissioner Robert Califf urged a change in clinical trial diversity discussions, emphasizing the need to consider the realities of US leadership in a global drug development ecosystem.
Flat-Lining US FDA: Failure To Invest May Have Consequences
Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum.
Flat-Lining US FDA: Failure To Invest May Have Consequences
Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum.
US NIH And Drug Pricing: Still Seeking A Balance
“Access Plans” are the US NIH’s new idea to address calls to take a more hands-on role in regulating the prices of products developed with taxpayer funding, but what the policy would actually mean for prices is hard to pin down, and that is probably deliberate.
US FDA’s ‘Platform’ Pathway Fits For LNPs And siRNA But Not Delivery Devices
The US FDA’s new guidance defining a “Platform Technology Designation” makes clear that what counts as a “platform” may not match industry’s use of the term.