CBER Urges Sponsors to Adopt International Standards

December 20, 2017

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— as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance.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.

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