RECALLS ----------------------------------------------------------------------------------------------------------------- FDA Enforcement Report CBER Recalls / Withdrawals / Safety Issues CBER Enforcement Actions

WARNING LETTERS ----------------------------------------------------------------------------------------------------------------- Warning Letters and Notice of Violation Letters Warning Letters by Subject Most Recent Warning Letters Warning Letters by Issuing Office Warning Letters Indexed by Date Warning Letters by Company

CLINICAL / IRB / GCP ----------------------------------------------------------------------------------------------------------------- Disqualified/Restricted/Assurances List for Clinical Investigators Debarment List Enforcement of the Postmarketing Adverse Drug Experience Reporting Regs Laboratory Procedure Manual PHS Administrative Action Detailed Listing IRB/Clinical Information Sheets Bioresearch Monitoring Information File FDA Compliance Program Guidance FDA Enforcement Report HHS Office of Research Integrity FDA Guideline for Monitoring of Clinical Investigations OHRP- Office for Human Research Protections OHRP Compliance Common Findings & Guidance OHRP Compliance Oversight Procedures OHRP Guidance Topics by Subject OHRP IRB Registration and Assurance Filing OHRP Policy Guidance Society of Quality Assurance British Association of Research Quality Assurance (BARQA) Japan Society of Quality Assurance (in Japanese) Mid-Atlantic Region of the Society of Quality Assurance North Carolina Chapter of SQA Pacific Regional Chapter of the Society of Quality Assurance Quality Assurance Professional Certification Rocky Mountain Regional Chapter of the Society of Quality Assurance

PHARM / TOX / GLP COMPLIANCE ----------------------------------------------------------------------------------------------------------------- FDA Enforcement Report FDA Compliance Program Guidance Society of Quality Assurance (SQA) British Association of Research Quality Assurance (BARQA) Pacific Regional Chapter of the Society of Quality Assurance Rocky Mountain Regional Chapter of the Society of Quality Assurance Midwest Regional Chapter of the Society of Quality Assurance

EUROPEAN GLP DIRECTIVES ----------------------------------------------------------------------------------------------------------------- European GLP Directives BARQA GLP Q&A Page Guide to UK GLP Regulations 1999 UK Good Laboratory Practice Guidance UK GLP Monitoring Authority Code of Practice UK GLP Application to Computer Systems UK GLP Application to Field Studies UK GLP & the Role of Quality Assurance UK GLP & the Role of Study Director UK GLP Application to Safety Studies on Biologics

CMC / GMP ----------------------------------------------------------------------------------------------------------------- FDA Enforcement Report Application Integrity Policy Information Inspector's Technical Guide cGMP Notes Drug Registration and Listing Drug Application Regulatory Compliance Establishment Evaluation System (EES) Private Laboratory Grassroots Meetings Laboratory Procedure Manual FDA Field Management Directives FDA Inspection Guides FDA Inspectional Methods FDA Investigations Operations Manual FDA Compliance Policy Guides FDA Compliance Guidance Manual Pharmaceutical Inspection Cooperation Scheme PIC/S UK GMP & GDP Medicines Inspectorate

ADVERSE EVENT REPORTING ----------------------------------------------------------------------------------------------------------------- Enforcement of Postmarketing ADE Regulations

CBER ----------------------------------------------------------------------------------------------------------------- CBER Enforcement Actions

MEDICAL DEVICES ----------------------------------------------------------------------------------------------------------------- Bioresearch Monitoring Office of Compliance Draft Compliance Program Guidance Manual: Inspection of Medical Devices Medical Device Warning Letter Pilot IRB/Clinical Information Sheets FDA/ORA Compliance Policy Guides