Snapshot

The FDA CPP for Unapproved Products pathway has been developed by the US Food and Drug Administration of United States.

It is an abridged review (a reliance pathway).

CPPs are normally issued within twenty (20) government working days of application receipt. Certification may not be issued (1) Returned with a letter requesting additional information or missing information required in the CPP application (2) Rejected: manufacturing facility status concerns (e.g. a violative facility inspectional status in FDA systems) (3) Denied: drug is not in compliance with applicable regulation (e.g. misbranding not covered by an exemption)