FDA officials detailing the agency’s new expedited IND pilot program say a central feature will be a rolling pre-IND submission process.
A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.
FDA officials detailing the agency’s new expedited IND pilot program say a central feature will be a rolling pre-IND submission process.
A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.
FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products.
Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products.
