FDA CIRCULAR NO. 2011-002

: Pharmaceutical companies are required to submit a Certified True Copy of valid Certificate of Product Registration (CPR), the previously approved insert, clinical data justifying the changes or revisions, and a tabulated list of proposed changes with sections of the application tagged and labeled.
: Applications that include any indication not previously approved by the FDA shall be subject to appropriate FDA sanctions as deemed applicable.
: Indications approved by the FDA should be stated exactly as worded in the application submitted for the indication.
: Three (3) clinical studies must be submitted to justify changes made, particularly those related to new dosages and new routes of administration.
: Any changes in the Core Data Sheet or Basic Succinct Statements must be previously approved by the FDA before any product insert revision is undertaken.
: Companies are required to submit three (3) copies of the approved product insert within 30 days of receipt of the approval letter.
: Companies may apply to revise or update the package insert or labels, patient leaflet information, prescribing information, Core Data Sheet (CCDS), and basic succinct statement.
: Sections of the application must be tagged and labeled to clearly identify proposed changes.
: Ensuring submissions and supporting documents are in order is important for strict compliance and to avoid sanctions or delays in approval processes by the FDA.