Translational Clinical Research

Clinical Trial Designing and Management References

Dec 10, 2010

The Evolving US 510(k) Review Process

The Evolving US 510(k) Review Process
Email ThisBlogThis!Share to XShare to FacebookShare to Pinterest
Posted by Unknown

No comments:

Post a Comment

Newer Post Older Post Home
Subscribe to: Post Comments (Atom)

Clinical Study Guidelines & Regulations

  • Non-local IRB Review
  • 21 CFR 314 applications for FDA approval to market a new drug
  • 21 CFR 312 investigational new drug application
  • 21 CFR 50 protection of human subjects (FDA)
  • 45 CFR 46 protection of human subjects (HHS)
  • Comparison of FDA and HHS human subject protection regulations
  • 21 CFR 54 finical disclosure by clinical investigators
  • 21 CFR 56 institutional review boards
  • 21 CFR 812 investigational device exemptions (IDE)
  • 21 CFR 820 quality system regulation
  • AHRG guideline: Machine perfusion & cold storage of kidney from deceased donors storage of
  • Adaptive Design Clinical Trials for Drugs and Biologics
  • Common Terminology Criteria for Adverse Events (CTCAE)
  • Comparison of FDA and HHS Human Subject Protection Regulations
  • Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
  • Device Advice: Comprehensive Regulatory Assistance
  • FDA Clinical Investigator Training Course 2011
  • FDA Clinical Trial Draft Guidance Documents : GCP
  • FDA Device comprehensive regulatory assistance
  • FDA For Health Professionals Topics
  • FDA Guidance on IDE Policies & Procedures
  • FDA Guidance:Safety Reporting Requirements for INDs and BA/BE Studies -- Small Entity Compliance Guide, Dec. 2012
  • FDA IDE Tutorial for Academic Investigators
  • FDA Master Files for Devices (MAFs)
  • FDA Medical Device Cross-Center Guidance Documents
  • FDA Training and Continuing Education
  • FDA guidance for IDE application
  • FDA guidance: Safety Reporting Requirements for INDs and BA/BE Studies Dec. 2012
  • FDA guideline and regulation: IDE Approval Process
  • FDA's HSP/BIMO Initiative Accomplishments: Update May 2012
  • FDA: How Drugs are Developed and Approved
  • Guidance for Industry Non-Inferiority Clinical Trials
  • Guidance on Exculpatory Language in Informed Consent (Aug. 2011)
  • HHS.gov -- Policy & Guidance
  • Human Subject Regulations Decision Charts
  • Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
  • Medical Device Cross-Center Guidance Documents
  • Medical Device Quality Systems Manual
  • NHS (uk) -- Kidney Transplantation
  • ORA University State Training Courses and Training Materials
  • Progress & Challenges in Efficacy, Safety, and Paths to IV Immune Globuline (FDA, 2005)
  • Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
  • Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices
  • The Belmont Report
  • US Patent and Trademark Office
  • Waived Test

Renal Transplant Useful Links

  • FDA 510(k) applications and decisions collected since 1996
  • FDA requirements for IDE sponsors
  • Flow Cytometry Introduction 1 (Invitrogen)
  • Flow Cytometry Introduction 2 (Invitrogen)
  • Induction Therapy in Kidney Transplantation

Study Management Tools

  • FDA Audit Preparation Resource & Checklist - Johns Hopkins 2013
  • FDA Guidance -- A Risk-Based Approach to Monitoring
  • Strategies for Clinical Investigators to Build Quality into Device Research
  • National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)
  • Billing for Patient Care in Clinical Research Studies
  • REGULATORY DOCUMENTS -- UT Health Science Center at Houston
  • What Makes A Top 10 Site
  • Strategies for Clinical Investigators to Build Quality into Device Research
  • NEGOTIATING CONTRACTS FOR CLINICAL TRIALS
  • Clinical trial design — for beginners
  • FDA GCP training
  • Clinical Research Forum
  • SOPs
  • CTN clinical trial tools, templates, training

Research Methodology

  • Comparative effectiveness research
  • Design and Analysis Clinical Trials
  • NIH guidelines for writing research protocols
  • NIH Stem Cells: Scientific Progress and Future Research Directions
  • Prepare a protocol for the study

Translational Clinical Research Institute Links

  • Childern's Hospital Boston
  • Clinical Research Networks
  • Duke
  • National Electronics Clinical Trials and Research
  • NIH CTSA
  • Resources for Researchers
  • The Institute for Translational Sciences -- UTMB
  • UC San Diego CTSI
  • UCDHS CTSC
  • UCLA CTSI
  • UCSF Clinical Research Resource HUB
  • UCSF CTSI

Clinical Trials at UC Davis

  • Accounts Receivable
  • CCRC Accessing Support Process
  • Clinical Research Billing Education Series
  • Clinical Research Quality Assurance Program for Investigator-Initiated Interventional Trials, UC Davis
  • Clinical Trials Contracts
  • Composite Benefit Rate
  • Indirect Cost Rate Applicable to Clinical Trials
  • UC Davis IRB Guidance
  • Home
  • Renal Transplant Study References
  • Health & Aging

Blog Archive

Tag Could

Busilvex (1) CHINA (2) CHMP (1) Caelyx (1) Clinical Trial (10) EDQM (1) EMA (1) EU (1) FDA (8) FDA guidance (5) FDA recall (2) GMP (2) ICH (2) IDE (3) IND (2) Medical Device (6) NICPBP (1) NIHS (1) OTC (1) SFDA (6) Velcade (1) Vidaza (1) cosmetic (1) cosmetic substance (1) drug recall (1) pharmecutical (1) small business (1)

Find Me On Linkedin

View Ying Lu's profile on LinkedIn
  • Alliance for paired donation

Reading List

  • A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim -- Margaret Liu
  • A Manager's Guide to the Design and Conduct of Clinical Trials -- Phillip I. Good
  • Applied Survey Data Analysis -- Steven G. Heeringa
  • Clinical Epidemiology: How to Do Clinical Practice Research -- R. Brian Haynes
  • Clinical Evaluation of Medical Devices: Principles and Case Studies -- Karen M. Becker
  • Clinical Research Coordinator Handbook -- Deborrah Norris
  • Clinical Trial Methodology -- Karl E. Peace
  • Design, Execution, and Management of Medical Device Clinical Trials -- Salah Abdel-aleem
  • Goodman and Gilman's The Pharmacological Basis of Therapeutics -- Laurence Brunton
  • Guidebook for Drug Regulatory Submissions -- Sandy Weinberg
  • Principles and Practice of Clinical Trial Medicine -- Richard Chin
  • Statistical Evidence in Medical Trials: Mountain or Molehill, What Do the Data Really Tell Us? -- Stephen Simon
  • Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics -- Linda Fossati Wood
  • The CRA's Guide to Monitoring Clinical Research -- Karen E. Woodin

Google Analytics
Ying Lu Consulting. Theme images by gaffera. Powered by Blogger.