User Fees, Timelines & Review

An FDA letter at the end of a review cycle stating that the application cannot be approved in its current form and describing deficiencies to address.

A regulator communication identifying deficiencies or gaps that must be addressed to progress review or approval.

An early FDA review step to determine whether an NDA/BLA is sufficiently complete to permit substantive review (leading to “filed” or “refuse-to-file”).

A later-stage EU review list (often Day 180) highlighting remaining major issues that must be resolved to support a positive opinion.

A set of questions issued during review (commonly EU Day 120) requiring applicant responses to address identified deficiencies or clarifications.

An EU review term for significant issues that must be addressed to support a positive opinion during an assessment procedure.

A US user fee program under which sponsors pay fees to support FDA’s review capacity, in exchange for performance goals and target timelines for certain applications (e.g., NDAs/BLAs).

An FDA decision not to accept an NDA/BLA for review due to missing or inadequate required content or organization.

A regulator request seeking clarifications or additional information during review that must be tracked, answered, and archived with traceability.

A structured set of documents and data submitted to address regulator questions/deficiencies (e.g., LoQ responses, CRL responses).

A sponsor’s response package submitted to address review deficiencies (e.g., after a CRL), potentially starting a new review clock depending on classification.

A defined period of regulatory assessment for an application, typically starting at filing/validation and ending at an action (approval, CRL, opinion).

A default regulatory review timeline and process (e.g., in FDA PDUFA terms, standard review has a longer goal date than priority review).