CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.
The proposed program would allow stakeholders and CDER staff to submit quality-related voluntary consensus standards for “informal” recognition. The system, which differs from CDRH’s formal recognition standards program, “will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications” for CDER-regulated products, the draft guidance states.
Standards would be listed in a publicly searchable database on CDER’s website if they are recognized by the center. Accepted standards would also be supplemented with information explaining their scope and the extent of CDER’s informal recognition.