Product Quality/Safety

Order by:Group by:

Anti-Corruption, Competitive Practices, Employment, Environmental, Financial Assurance, Governance, Government Dealings (USA), Intellectual Property, Product Quality/Safety, Workplace Health/Safety

Mitratech

Anti-Corruption, Product Quality/Safety

FDA Debarment List

Anti-Corruption, Employment, Environmental, Governance, Government Dealings (USA), Information Management, Product Quality/Safety, Supply Chain Management (SCM)

SAS Institute, Inc.

Competitive Practices, Product Quality/Safety

Drugs; General (21 C.F.R. Part 200 et. seq.)
CSR And Sustainability: Local Impacts Of Global Supply Chains (2007)

Employment, Product Quality/Safety, Workplace Health/Safety

Japan, Ministry of Health, Labour and Welfare

Environmental, Product Quality/Safety

International Organization for Standardization (ISO) – Understand the basics

Environmental, Financial Assurance, Governance, Information Management, Product Quality/Safety, Supply Chain Management (SCM), Workplace Health/Safety

Cura Software Solutions

Product Quality/Safety

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
FDA, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996)
FDA/CDER, Guidance Documents Page
FDA, International Organizations and Foreign Government Agencies
HHS/OIG Compliance Guidance
NIH, ClinicalTrials.gov
Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008)
FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective, The (2002, 2005)
PharmAsia News
Prescription Drug Marketing Act (PDMA) - Relevant Laws and Legislative History
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 for Human Use (21 C.F.R. Part 300 et seq.)
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
Japan, Pharmaceuticals and Medical Devices Agency (PMDA)
Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA)
Bristol-Myers Squibb : Compliance & Ethics