FDA Expects Fewer Duplicate Requests for Data in Reviewing Drug/Diagnostic NDAs

Developers of drugs with companion diagnostics should see fewer requests for duplicate data from CDRH and CDER, as the FDA begins to see payoffs from its effort to increase communication between its centers. Chris Leptak, medical officer in CDER’s Office of New Drugs, said that over the last four years the agency has worked to break down the silos within the FDA as more new products cross drug-device barriers.
Drug Industry Daily