Engaged. Knowledge. Application
GCP Enforcement
FDA 2011 GCP Enforcement
New! -
FDA has issued draft guidance on "Oversight of Clinical Investigations: A Risk-Based Apporach to Monitoring" - click here for download
Note - Comments to this draft are due by November 28, 2011
***Help ensure your company's compliance with current FDA GCP-related enforcement with Clinical Monitoring CONTENT Power Package
FDA has issued the final guidance Exception from Informed Consent Requirements for Emergency Research - click here for download
FDA has issued a revised Compliance Program Guidance Manual (CPGM) for inspections of Sponsors, Contract Research Organizations and Monitors (CP 7348.810). The document is now available - click here
New Final Guidance Issued
The guidance document for Clinical Investigators, Sponsors, and IRBs - Improving Human Subject Protection has been updated from the draft guidance document to the final guidance document - click here to download final guidance
New GCP Regulation Amendment
Help ensure your company's compliance with this new regulation amendment:
Informed Consent CONTENT Package
New GCP Draft Guidance Document
Electronic Source Documentation in Clinical Investigations Guidance Document: Draft Guidance
Help ensure your company's compliance with electronic documents:
Part 11 CONTENT Power Package
GCP Regulations
Protection of Human Subjects - 21 CFR Part 50 - Click Here
Financial Disclosure By Clinical Investigators - 21 CFR Part 54 - Click Here
Institutional Review Boards - 21 CFR Part 56 -Click Here
Investigational New Drug Application - 21 Part 312 - Click Here
Investigational Device Exemptions - Part 812 -Click Here
ICH E6 Good Clinical Practice: Consolidated Guideline - Click Here
GCP - Warning Letters
Orthocon, Inc. ... January 6, 2011
Multiple GCP Violations
Help ensure your company's compliance with current FDA GCP-related enforcement with Ensuring GCP Quality Content Package.
Marquette General Health Systems ...January 18, 2011
Multiple Institutional Review Board-related violations.
Warning Letter excerpts:
"Failure to require that information given to subjects as part of informed consent is in accordance with 21 CFR 50.25"
"Your IRB failed to follow its continuing review procedure"
"Failure to maintain adequate documentation of IRB activities including minutes of meetings 21 CFR 56.115 (a)(2)."
Help ensure your company's compliance with FDA regulations with enKap's CONTENT Packages:Institutional Review Board CONTENT Package, Informed Consent CONTENT Package and GCP Enforcement Trends CONTENT Package.
Napoli LLC (dba Precision Reproduction) ... January 21, 2011
Multiple Institutional Review Board - related violations
Warning Letter excerpts:
"An IRB must be comprised of 5 members ...your sworn, signed affidavit ...consisted of yourself and an embryologist."
"Failure to have adequate written procedures governing the functions and operations of the IRB."
Help ensure your company's compliance with FDA regulations with enKap's CONTENT Packages:Institutional Review Board CONTENT Package and GCP Enforcement Trends CONTENT Package.
Mancha, Vaughn H. Jr., M.D. ...February 17, 2011
Simmons, John F., M.D. ...February 18, 2011
Margaret Thurmond-Anderle, M.D. ... February 25, 2011
John Griffin, M.D. ...March 14, 2011
Dr. Jeffrey Horowitz ... March 21, 2011
Dr. Martin N. Zaiac...March 21, 2011
American Association of Acupuncture Bio-Energetic Medicine... March 24, 2011
Valor Medical, Inc. ...March 24, 2011
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