FDA Regulatory Process and Issues文档.ppt

Challenge of Combination Products CDRH CDER CBER NDA, BLA PMA, 510(K) IND, IDE Device Drug Biologic IND, NDA IDE, PMA, 510(k) IND, BLA CDER CDRH CBER Drug Device Biologic Different Frameworks Different Product Types Different FDA Reviews * Challenge of Combination Products Product Pre-Market Framework Approval FDA Reviewing Center Quality System Safety Reporting Device IDE PMA, 510(k) CDRH QSR MDR Drug IND NDA CDER GMP AERS Biologic IND BLA CBER /CDER GMP AERS Regulatory Complexity * Drug Matrix Drug – polymer compatibility Loading capacity Release kinetics Pharmacology Polymer Chemistry Stent Tissue Mechanical scaffolding Mechanical Engineering Vascular Biology Coating integrity Vascular biology Tissue pharmacokinetics Preclinical models Vascular biology Drug Eluting Stent System Design Slide courtesy of Nadine Ding, Guidant Corporation * Real World Examples Drug-eluting stent CDRH Drug-eluting disc (oncology) CDER Contact lens/glaucoma drug CDER Contact lens/glaucoma drug (new submission) CDER Spinal fusion device/therapeutic protein CDRH Chemo drug/monoclonal antibody CDER Scaffold seeded with autologous cells CBER Interferon/Ribivarin therapy CDER Embolization implant device/chemo drug CDRH Vertobroplasty device/analgesic CDRH * Links and Resources FDA Center for Devices and Radiological Health (CDRH) /cdrh/index.html FDA Office of Combination Products /oc/combination/ FDA US Agent/cdrh/usagent/index.html FDA Establishment and Device Listing Forms/scripts/cdrh/cfdocs/cfRL/printforms.cfm * Thank you For additional information contact:James Wason, Ph.D.T: 603-672-4678E:JWason@Maelor-G * FDA Regulatory Processes and Issues: A Practical Guide, June 2006 * FDA Regulatory Processes and Issues: A Practical Guide, June 2006 * FDA Regulatory Processes and Issues: A Practical Guide, June 2006 * FDA Regulatory Processes and Issues: A Practical Guide, June 2006 * FDA Regulatory Processes and Issues: A Practical Guide, June 2006 * FDA