Pharmaceutical | by OCEG the Open Compliance and Ethics Group

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

Mitratech

Anti-Corruption, Competitive Practices, Environmental, Financial Assurance, Governance, Government Dealings (USA), International Transactions, Workplace Health/Safety

BWise

Anti-Corruption, Product Quality/Safety

FDA Debarment List

Anti-Corruption

Fraud Risk Management in Life Sciences Companies (Deloitte, Rev. 2009)

False Claims Act

Pharmaceutical: Sales & Marketing Domain Supplement

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

SAS Institute, Inc.

Competitive Practices

PhRMA Code on Interactions with Healthcare Professionals (2008)

PhRMA's Marketing Code Touts Sarbanes/Oxley-esque Compliance Mechanism (2008)

Prescription Drug Advertising (21 C.F.R. Part 202 et seq.)

Competitive Practices, Product Quality/Safety

Drugs; General (21 C.F.R. Part 200 et. seq.)

Employment

PBM Transparency May Only Be Skin Deep (2007)

Financial Assurance, Governance, Information Management, Intellectual Property, International Transactions, Supply Chain Management (SCM)

OCEG for Technology

Government Dealings (USA)

HHS List of Excluded Individuals/Entities

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.)

Japan, Pharmaceuticals and Medical Devices Agency (PMDA)

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

Bristol-Myers Squibb : Compliance & Ethics