Forms & Submission Requirements
There is no form, but there is a prescribed format for application for orphan drug status. The section from the regulations that describes the format can be found on this website on the The Orphan Drug Act and Related Law and Regulations page.
Electronic Regulatory Submission and Review
Regulations and Instructions for Submitting Drug Applications Electronically. This webpage provides for information on CDER's program to enable the electronic submission of regulatory information to the Center and the review of it by CDER staff.
- Guidance for Industry: Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER
Guidelines for Waiver Requests
Guidelines for requesting waiver to current supported clinical study data standard versions. This webpage provides information on submission of data that does not conform to currently supported standard versions.
SNOMED CT Requirements
- NEW SNOMED CT will be required for FDA Forms 1571 and 356h. The instructions on how to fill out the SNOMED CT Indication Disease Term on the Forms 356h and 1571 see FDA Forms and SBIA Webinar. For more information on SNOMED CT see FDA Data Standards Catalog and Technical Conformance Guide.