Annual Reports ANDAs

CDER-approved products are considered those subject to an approved NDA or ANDA. Some information on which components/materials aie used in CDER-approved products is available from the Agency (e.g., FDA, CDER, Inactive Ingredient Guide, 1996, Division of Drug Information Resources). When infonnation is not available, an applicant should use reliable sources of infonnation to determine that the component or material has been used in and has been in contact with a CDER-approved product of the same dosage form and route of administration, as appropriate. The applicant should identify in the supplement or annual report the basis for the conclusion that the component or material is used in a CDER-approved product. 

For meeting requests, orphan-drug applications, INDs, NDAs, 505b(2) NDAs, Abbreviated New Drug Applications (ANDAs), Orphan Annual Reports, and Annual Reports, the tools, checklists, and FDA guidelines are provided. With this tool kit, your organization can regain control of a rational, predictable submissions process. 

Type of submission (ANDA, AADA, amendment, supplement, annual report, or resubmission as a result of prior withdrawal of an application)... 

The end result of a successful NDA [traditional or 505(b)2] or ANDA is FDA approval to sell the drug product in the United States. The required annual reports are therefore described as Postmarketing Reports. 

This checklist is intended for use in the preparation and submission of Annual Reports for Orphan-Drug Applications, INDs, NDAs [standard and 505(b)2], and ANDAs. It is recommended that, prior to transmission to the FDA, a second internal review should be conducted by an individual or department not involved in the preparation of the submission (presumably Quality Assurance). 

This Annual Report Review checklist for Orphan Drugs, INDs, NDAs [both standard and 505(b)2], and ANDAs has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Center for Drug Evaluation and Research (CDER) and the Center for Biologies Evaluation... 

Stability data should be included in the application (NDA, ANDA, BLA, PLA, IND, supplement) they are intended to support. The extent of stability data expected at the time of submission is discussed at length throughout this guidance. Additional data from ongoing studies and regular annual batches should be included in the application s annual report. 

---