Resources for Applicants and Grantees
- Orphan Products Grants Overview
- Sponsor-Investigator Roles and Responsibilities in Clinical Investigations for Drug and Biological Orphan Products
- Video Discussion on Natural History Studies
- Workshop on Natural History Studies in Rare Diseases: Meeting the Needs of Drug Development and Research
- How Rare Disease Patients Can Move Scientific Discovery Forward
- Natural History Video for Grant Applicants
- Patient Affairs Staff: Patients Matter Video Series
- Application Guide: How to Apply NIH Resources
- FDA’s Role: ClinicalTrials.gov Information
IND
- Rare Diseases Early Drug Development and the Role of Pre IND Meetings
- IND Application Information and Procedures
- Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
- Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting
Highlighted Guidances