National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

About | Ordering | New

Menu menu

| Items in cart [0]

The National Academies Press

PAPERBACK
price:$36.00
add to cart

Rights & Permissions

topleft topright

Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary (2008)
Board on Health Sciences Policy (HSP)

Citation Manager

Wizemann, Theresa, Robinson, Sally, Giffin, Robert. "Appendix C: Resources." Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary. Washington, DC: The National Academies Press, 2008.

Please select a format:

BibTeX EndNote RefMan
Page
129
bottomleft bottomright
  E-mail
Share on facebook Facebook
Share on delicious Delicious
Share on stumbleupon Stumble
Share on twitter Twitter
More Sharing ServicesMore

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.

Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies - Workshop Summary

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

 Page
129