Latest From Michael McCaughan
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.
Upcoming retirement of Janet Woodcock will mean loss of one of agency's FDA’s most experienced and influential drug regulators. However, CDER still has plenty of long-tenured staff peppered across all its key functions.
The upcoming retirement of Janet Woodcock will mean the loss of one of the US FDA’s most experienced and influential drug regulators. However, the drug center still has plenty of long-tenured staff peppered across all of its key functions.
The push for dose optimization in oncology should incorporate patient experience data, a Friends of Cancer Research White Paper recommends. ‘Tolerability’ is a key element to define in early development, and patient-reported outcomes can help.
The National Academy of Medicine is launching a Congressionally mandated study of the US FDA’s regulatory approach to rare disease treatments. The first question is whether there is anything more that FDA can do.
Final rule on the so-called ‘major statement’ in direct-to-consumer broadcast ads comes 15 years after the law it is implementing. A lot has changed in the advertising world since then – but FDA says the principles of ‘clear, conspicuous and neutral’ presentation of risk information still apply.