Product Quality/Safety

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OCEG Contributed

CSR And Sustainability: Local Impacts Of Global Supply Chains (2007)
FDA/CDER, Guidance Documents Page
Prescription Drug Marketing Act (PDMA) - Relevant Laws and Legislative History
FDA, International Organizations and Foreign Government Agencies
Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008)
HHS/OIG Compliance Guidance
GAO, FDA's Oversight of the Promotion of Drugs for Off-Label Uses (2008)
FDA, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004)
PharmaManufacturing.com - Regulatory Compliance Site
NIH, ClinicalTrials.gov
FDA Debarment List
FDA, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996)
FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective, The (2002, 2005)
CPSC, Regulations, Laws & Information for Manufacturers, Importers, Distributors & Retailers
CPSC, Businesses: Report a Potentially Defective or Hazardous Product: Office of Compliance - Section 15(b) Internet Report
Federal Food, Drug, and Cosmetic Act
Prescription Drug Marketing Act of 1987
Public Health Service Act
Prescription Drug Marketing (21 C. F. R. Part 203)
Drugs; General (21 C.F.R. Part 200 et. seq.)
Drugs for Human Use (21 C.F.R. Part 300 et seq.)

Member Contributed

International Organization for Standardization (ISO) – Understand the basics
Bristol-Myers Squibb : Compliance & Ethics
PharmAsia News
Japan, Ministry of Health, Labour and Welfare
Japan, Pharmaceuticals and Medical Devices Agency (PMDA)
Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA)
Mitratech
Cura Software Solutions
SAS Institute, Inc.