Orphan-Drug Annual Reports

Specifically, the Orphan-Drug Annual Report has three sections. 

Note that the first Orphan-Drug Annual report is due 14 months after status approval all other reports are due every 12 months thereafter. 

Comment 1) The comment suggested that our burden estimate to prepare an Orphan-Drug Annual Report is too low. 

An orphan-drug application and an IND both receive responses in about 30 days. Try to schedule submissions so that the response date will not fall within planned vacations or critical international travel. And both submissions (and many others) require an annual update report it is best to stagger report due dates to avoid complications in the future. 

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. 

Progress Report The progress report summarizing any actions (successful or unsuccessful, complete or in progress) since the last submitted report (14 months after initial Orphan-Drug Status or 12 months after the last Annual Report). If no action has been taken, a statement to that effect should be included. 

As with the Orphan-Drug update, the first report is due within 60 days of the anniversary of the in effect date (i.e., 90 days after the anniversary of the initial submission). Other annual reports are due every 12 months thereafter. 

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... 

---