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FDA: whether a revised PSG applies to a CRL response depends on case; controlled correspondence can clarify
Summary
FDA said whether a revised PSG (for example, changing a study condition from fed to fasting) applies when responding to a complete response letter depends on the facts of the submission; agency staff recommended controlled correspondence or a post-CRL scientific meeting to obtain a definitive answer.
An ANDA holder asked whether a revised PSG — for example, one that changes a BE study condition from fed to fasting — would be applied when responding to a complete response letter (CRL) issued under the earlier PSG. Dave, an agency responder, said it is fact specific: if the sponsor conducted studies consistent with prior PSG recommendations and the data meet the revised PSG's criteria, the studies could be sufficient, but the answer depends on the submission's details.
"So it could depend, obviously... it could be very fact specific," Dave said. He recommended controlled correspondence or, where appropriate, a post-CRL scientific meeting to obtain a definitive answer, noting specific criteria exist for the post-CRL meeting pathway.
Later in the session, when a moderator asked Dr. Kim whether an applicant could conduct a fed study when a PSG recommends fasting, Dr. Kim reiterated that the acceptability depends on labeling, safety considerations and drug properties; applicants should consult the RLD labeling and consider safety and formulation characteristics when choosing study conditions.
