Avid Bioservices Inc (CDMO)

[learningcurve2020]

understands that a sponsor cannot disclose for-
eign records that are prohibited from disclosure
by foreign law. Never theless, if the agency be-
lieves that access to records is necessary to verify
certain data or to validate the study and such
records are not available because of foreign law,
the sponsor and FDA will need to agree upon an
alternative validating procedure if the agency is
to rely on the data.