Eli Lilly, AbbVie, Johnson & Johnson, and Merck urge the U.S. Food and Drug Administration (FDA) to modify its drug approval process.
The firms cite concerns that linking pre-approval manufacturing facility inspections directly to the drug application review timeline causes significant delays in bringing new therapies to patients.
The pharmaceutical group advocates decoupling the facility inspection schedule from the drug approval timeline. They argue this change streamlines market access for new medicines without compromising regulatory standards for safety and quality.
These discussions underscore the ongoing dialogue between industry and regulators regarding process optimization.