CBER Urges Sponsors to Adopt International Standards
CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance.
The guidance does not endorse a specific set of standards for use in submissions, or a particular organization, but says their use can improve the efficiency of evaluations and time to market, compared to the use of a company’s in-house standards.
For biologic products regulated by CBER as a device, the FD&C Act of 1997 authorizes the agency to recognize certain standards that need to be met for premarket approval. Sponsors should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH.