Product Quality/Safety

Order by:Group by:

Automotive, Biotechnology, Chemical, Finance/Banking, Food/Agricultural, Government Agency or Entity, Health Care, Higher Education, Hospitality, Travel and Tourism, Insurance, Manufacturing, Oil & Gas, Pharmaceutical, Retail, Telecommunications, Transportation/Shipping, Utility

SAS Institute, Inc.

Biotechnology, Health Care, Pharmaceutical

Japan, Pharmaceuticals and Medical Devices Agency (PMDA)

Chemical, Finance/Banking, Health Care, Insurance, Legal, Manufacturing, Oil & Gas, Pharmaceutical, Retail, Technology, Telecommunications, Transportation/Shipping, Utility

Mitratech

Food/Agricultural, Pharmaceutical

FDA/CDER, Guidance Documents Page
FDA, International Organizations and Foreign Government Agencies

Health Care, Pharmaceutical

HHS/OIG Compliance Guidance
FDA Debarment List
Public Health Service Act

Manufacturing, Pharmaceutical

PharmaManufacturing.com - Regulatory Compliance Site

Manufacturing, Retail

CPSC, Businesses: Report a Potentially Defective or Hazardous Product: Office of Compliance - Section 15(b) Internet Report

Pharmaceutical

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)
FDA, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996)
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
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.)
Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA)
Bristol-Myers Squibb : Compliance & Ethics

Retail

CPSC, Regulations, Laws & Information for Manufacturers, Importers, Distributors & Retailers

Technology

Cura Software Solutions