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Appendix C
Resources
A number of resources mentioned throughout the workshop are available on the internet. The following list is provided as a starting point for those interested in the development of drugs for rare and neglected diseases. The Forum does not endorse any particular programs, publications, or websites.
ORGANIZATIONS AND INITIATIVES
National Organization for Rare Disorders (NORD)
http://www.rarediseases.org/
FasterCures, The Center for Accelerating Medical Solutions
http://www.fastercures.org/
See white paper: Entrepreneurs for Cures: The Critical Need for Innovative Approaches to Disease Research, May 30, 2008.
http://www.fastercures.org/objects/pdfs/white_papers/FastercuresWP_Innovation_052808.pdf
Drugs for Neglected Diseases initiative (DNDi)
http://www.dndi.org/
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
FDA
http://www.fda.gov/
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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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NATIONAL INSTITUTES OF HEALTH (NIH)
NIH Office of Rare Diseases
http://rarediseases.info.nih.gov/
Funding
NIH National Center for Research Resources (NCRR), Clinical and Translational Science Awards (CTSA)
http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs
http://grants1.nih.gov/grants/funding/sbirsttr_programs.htm
Guidelines and Standardized Agreements
Uniform Biological Material Transfer Agreement (UBMTA)
http://www.autm.net/aboutTT/aboutTT_umbta.cfm
Principles and Guidelines for Recipients of NIH Research Grants and Contract on Obtaining and Disseminating Biomedical Research Resources
http://www.ott.nih.gov/policy/reasearch_toolarchive.html
EXAMPLES OF DATA AND MATERIALS SHARING REPOSITORIES
NIH AIDS Research and Reference Reagent Repository
https://www.aidsreagent.org/Index.cfm
MR4: Malaria Research and Reference Reagent Resources Program
http://www.mr4.org/
BEI Resources: Biodefense and Emerging Infectious Diseases Research Resources Repository
http://www.beiresources.org/
ScienceCommons Biological Materials Transfer Project
http://sciencecommons.org/projects/licensing/
LONI Image Data Archive
https://ida.loni.ucla.edu/login.jsp?project=ADNI%2f
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Genetic Alliance BioBank
http://biobank.org
INTELLECTUAL PROPERTY MANAGEMENT
Socially Responsible Licensing at Berkeley—Humanitarian Use Clauses in Contracts
http://ipira.berkeley.edu/—then “Socially Responsible IP Management” link
CLINICAL TRIALS
Small Clinical Trials: Issues and Challenges (IOM report, full text free online)
http://www.iom.edu/CMS/3740/5483.aspx
ClinicalTrials.gov Registry
http://clinicaltrials.gov/
Declaration of Helsinki, the World Medical Association
http://www.wma.net/e/policy/b3.htm
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