Product Quality/Safety

Order by:Group by:

Multinational, Australia, New Zealand, Brazil, North America, European Union, Chile, India, California, Ecuador, Indonesia, Peru, Singapore, Massachusetts, United Kingdom, South Africa, Africa, Asia-Pacific, Europe, South America

Cura Software Solutions

Asia

PharmAsia News
Japan, Pharmaceuticals and Medical Devices Agency (PMDA)

Australia

Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA)

Japan

Japan, Ministry of Health, Labour and Welfare

Multinational

SAS Institute, Inc.

North America, United Kingdom

Mitratech

United States

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
FDA Debarment List
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)
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; General (21 C.F.R. Part 200 et. seq.)
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
CSR And Sustainability: Local Impacts Of Global Supply Chains (2007)
Bristol-Myers Squibb : Compliance & Ethics