FDA Office of Orphan Products Development

http://www.fda.gov/orphan/

Funding

FDA Orphan Products Grants Program

http://www.fda.gov/orphan/grants/index.htm


FDA Cooperative Research and Development Agreements

http://www.fda.gov/oc/ofacs/partnership/techtran/default.htm

Guidance for Industry

Fast Track Drug Development Programs—Designation, Development, and Application Review

http://www.fda.gov/cder/guidance/5645fnl.pdf


Formal Meetings with Sponsors and Applicants for PDUFA Products

http://www.fda.gov/cder/guidance/2125fnl.pdf


E 10 Choice of Control Group and Related Issues in Clinical Trials

http://www.fda.gov/cder/guidance/4155fnl.pdf


Special Protocol Assessment

http://www.fda.gov/cder/guidance/3764fnl.PDF

Code of Federal Regulations (CFR) and Federal Food, Drug, and Cosmetic Act (FFDCA)

Title 21: Food and Drugs (21 CFR) Chapter I: Food and Drug Administration, Department of Health and Human Services (Parts 1–1299)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm


21 CFR § 316 Orphan Drugs

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=316


Priority Review and Priority Review Voucher, FFDCA, Section 524

http://www.fda.gov/opacom/laws/fdcact/fdcact5b.htm



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