The Regulatory Process from Concept to Market

Principles of Tissue Engineering: Fourth Edition

Volumn , Issue , 2013, Pages 1781-1797

  Anatol, Rachael ^a   Arcidiacono, Judith ^a   Bailey, Alexander M ^a   Durfor, Charles N ^b   Fink, Donald W ^a   Holobaugh, Patricia ^a   Lee, Mark H ^a   McFarland, Richard ^a   Robinson, Becky ^b   Winitsky, Steve ^a   Witten, Celia ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

And Gene Therapies; Biologics; Biologics Licensing application; Cell therapy; Cell based product; Chemistry; Clinical investigation; Food and Drug Administration; Investigational New Drug Application; Manufacturing and controls; Office of Cellular; Pharmacology toxicology; Regulatory; Scaffold; Sponsor; Tissue

Indexed keywords

CELLULAR MANUFACTURING; CHEMISTRY; CLINICAL RESEARCH; CONTROLLED DRUG DELIVERY; CYTOLOGY; DRUG PRODUCTS; GENES; SCAFFOLDS; TISSUE;

BIOLOGICS; CELL THERAPY; CELL-BASED; CLINICAL INVESTIGATION; FOOD AND DRUG ADMINISTRATION; INVESTIGATIONAL NEW DRUGS; LICENSING APPLICATIONS; OFFICE OF CELLULAR; PHARMACOLOGY/TOXICOLOGY; REGULATORY; SPONSOR;

SCAFFOLDS (BIOLOGY);

EID: 84903256772     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-398358-9.00086-0     Document Type: Chapter

References (44)

1. Chemistry, Manufacturing, and Control Focus.
2. FDA 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) 2008, [accessed 10.08.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/ucm092705.pdf.
3. FDA 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) 2008, [accessed 10.08.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm078694.pdf.
4. FDA Guidance for industry: CGMP for phase 1 investigational drugs 2008, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070273.pdf.
5. FDA Guidance for industry: characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications 2010, [accessed 10.08.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf.
6. FDA Guidance for industry: potency tests for cellular and gene therapy products 2011, [accessed 10.08.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM243392.pdf.
7. FDA Amendments to sterility test requirements for biological products 2012, [accessed 10.08.12]. http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf.
8. Pharmacology and Toxicology Focus.
9. ICH M3(R2) nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals 2008, [accessed 10.08.12]. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129524.pdf.
10. Clinical Focus.
11. FDA Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products 1998, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078749.pdf.
12. FDA Guidance for industry: special protocol assessment 2002, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.
13. FDA Guidance for clinical investigators, institutional review boards and sponsors-process for handling referrals to FDA under 21 CFR 50.54-additional safeguards for children in clinical investigations 2006, [accessed 10.08.12]. http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0172-gdl0002.pdf.
14. FDA Draft guidance for industry: oversight of clinical investigations - a risk-based approach to monitoring 2011, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf.
15. FDA Guidance for industry and FDA staff: FDA acceptance of foreign clinical studies not conducted under an IND frequently asked questions 2012, [accessed 10.08.12]. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf.
16. Device and Combination Product Focus.
17. FDA Use of international standard ISO-10993, 'biological evaluation of medical devices part 1: evaluation and testing 1995, [accessed 10.08.12]. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm.
18. FDA Guidance for industry and FDA staff - early development considerations for innovative combination products 2006, [accessed 10.08.12]. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126054.pdf.
19. FDA Guidance for industry and/or for FDA reviewers/staff and/or compliance: preparation of a Premarket Notification Application for a surgical mesh 2009, [accessed 10.08.12]. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073791.pdf.
20. Draft guidance for industry and FDA staff-medical devices: the pre-submission program and meetings with FDA staff 2012, FDA, [accessed 10.08.12]. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.
21. Human cells, tissues and cellular and tissue-based therapies (HCT/P) Focus.
22. FDA Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) 2007, [accessed 10.08.12]. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf.
23. FDA Donor eligibility final rule and guidance questions and answers 2009, [accessed 10.08.12]. http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm102842.htm.
24. Regulatory Focus.
25. FDA OMB circular A-119: federal participation in the development and use of voluntary consensus standards and in conformity assessment activities 1998, [accessed 10.08.12]. http://standards.gov/standards_gov/a119.cfm.
26. FDA Early collaboration meetings under the FDA Modernization Act (FDAMA); final guidance for industry and for CDRH staff 2001, [accessed 10.08.12]. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073611.pdf.
27. FDA Guidance for sponsors, industry, researchers, investigators, and FDA staff - certifications to accompany drug, biological product, and device applications/submissions: compliance with Section 402(j) of The Public Health Service Act, 42 USC. § 282(j), added by Title VIII of the Food and Drug Administration Amendments Acts of 2007 2009, [accessed 10.08.12]. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm.
28. FDA Guidance for industry: formal meetings between the FDA and sponsors or applicants 2009, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm153222.pdf.
29. FDA Guidance for industry: investigator responsibilities - protecting the rights, safety, and welfare of study subjects 2009, [accessed 10.08.12]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf.
30. FDA Final Rules for expanded access to investigational drugs for treatment use and charging for investigational drugs 2009, [accessed 10.08.12]. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm172492.htm.
31. FDA FDA forms 2010, [accessed 10.08.12]. http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.
32. FDA Information sheet guidance for sponsors, clinical investigators and IRBs: frequently asked questions-statement of investigator (Form FDA 1572) 2010, [accessed 10.08.12]. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf.
33. FDA Information for sponsor-investigators submitting investigational new drug applications (INDs) 2011, [accessed 10.08.12]. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm071098.htm#form1571.
34. FDA Staff Manual Guide 9100.1: development and use of standards 2011, [accessed 10.08.12]. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM240278.pdf.
35. FDA OCTGT learn 2011, [accessed 10.08.12]. http://www.fda.gov/biologicsbloodvaccines/newsevents/ucm232821.htm.
36. FDA Office of Combination Products 2011, [accessed 10.08.12]. http://www.fda.gov/CombinationProducts/default.htm.
37. FDA Strategic plan for regulatory science 2011, [accessed 10.08.12]. http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm.
38. FDA Device advice: comprehensive regulatory assistance 2012, [accessed 10.08.12]. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
39. FDA Guidance documents (medical devices and radiation-emitting products) 2012, [accessed 10.08.12]. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
40. FDA Premarket Approval (PMA) 2012, [accessed 10.08.12]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.
41. FDA 510(k) premarket notification 2012, [accessed 10.08.12]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
42. FDA Recognized consensus standards 2012, [accessed 10.08.12]. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
43. FDA International programs 2012, [accessed 10.08.12]. http://www.fda.gov/InternationalPrograms/default.htm.
44. Wonnacott K., Lavoie D., Fiorentino R., McIntyre M., Huang Y., Hirschfield S. Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy. Cytotherapy 2008, 10(3):312-316.