FDA to revamp drug reviews

FDA Commissioner Scott Gottlieb Wednesday described the agency’s plans to revamp the drug review process, including initiatives intended to make reviews more consistent and to support the creation of hundreds of product-specific drug development guidance documents. Gottlieb presented FDA’s plans for investing the $400 million FY19 funding boost the Trump administration has requested (see BioCentury, Feb. 16).

In remarks to the House Appropriations Committee's subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Gottlieb said the centerpiece for the planned improvements in FDA’s medical product review procedures is a knowledge management platform...