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Regulatory Resources
Up one levelNEW REGULATIONS OR GUIDANCE |
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| Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 4/9/2008 | http://www.fda.gov/CBER/gdlns/cmcsomcell.htm |
| Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) - 4/9/2008 | http://www.fda.gov/CBER/gdlns/gtindcmc.htm |
| Draft Guidance: Adverse Event Reporting-- Improving Human Subject Protection | http://www.fda.gov/cber/gdlns/advreport.pdf |
REGULATIONS |
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| Code of Federal Regulations (Main Page) | http://www.gpoaccess.gov/cfr/index.html |
| FDA | |
| FDA Regulations Relating to Good Clinical Practice and Clinical Trials | http://www.fda.gov/oc/gcp/regulations.html |
| FDA CDER Guidances (Center for Drug Evaluation and Research) | http://www.fda.gov/cder/guidance/ |
| FDA CBER Guidances (Center for Biologic Evaluation and Research) | http://www.fda.gov/Cber/guidelines.htm |
| FDA CBER Guidances (Center for Devices and Radiological Health | http://www.fda.gov/cdrh/guidance.html |
| Federally Funded Studies | |
| Title 45--Public Welfare. Part 46--Protection of Human Subjects | http://www.ucop.edu/raohome/certs/45cfr46.html |
IND/IDE REGULATIONS/GUIDANCES/FORMS/INSTRUCTIONS |
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| Investigations New Drug Application (21 CFR 312) | http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr312_07.html |
| Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer | http://www.fda.gov/cber/gdlns/indcancer.pdf |
| Information on Submitting an Investigational New Drug Application | http://www.fda.gov/cber/ind/ind.htm |
| Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products | http://www.fda.gov/cber/gdlns/mtpdufa.pdf |
| Investigational New Drug (IND) Application Process | http://www.fda.gov/cder/Regulatory/applications/ind_page_1.htm |
| Investigational Device Exemption (IDE) Process | http://www.fda.gov/cdrh/devadvice/ide/application.shtml |
| Investigational New Drug (IND) Guidances | http://www.fda.gov/cber/ind/indpubs.htm |
| FDA 1571 Investigational New Drug Application | http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1571.pdf |
| FDA 1572 Statement of Investigator | http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.pdf |
| Instructions for completing FDA forms 1571 and 1572 | http://www.fda.gov/cder/forms/1571-1572-help.html |
| For electronic form submissions, see ERSR | http://www.fda.gov/cder/regulatory/ersr/default.htm |