FDA's memorandum of agreement between drug safety and drug review officials clarifies the processes by which decisions are made on significant safety issues. But one former FDAer thinks that reorganizing the center for drugs is still necessary to ensure a productive approval process.
When it comes to addressing internal strife at FDA’s Center for Drug Evaluation & Research, one former agency official wants to tear the walls down.
Scott Gottlieb, a resident fellow at the American Enterprise Institute and a former deputy commissioner at FDA, thinks the agency...
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
