The US Food and Drug Administration’s drug industry two-step – providing development advice while also independently assessing applications – continues to run smoothly, but Commissioner Robert Califf does not want its dual role taken for granted.
Califf: Industry Should Be Reminded Of US FDA’s Separate Development Advice, Application Assessment Roles
Experts wonder why the FDA Commissioner commented on a system seemingly working fine, but Califf says it is necessary to remember the potential conflict between the two roles.
More from RAPS
More from Pink Sheet
• By
Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
• By
The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
• By
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.