Pharmaceutical | by OCEG the Open Compliance and Ethics Group

Asia

PharmAsia News

Japan, Pharmaceuticals and Medical Devices Agency (PMDA)

Australia

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

Multinational

BWise

PharmaLive.com

SAS Institute, Inc.

Journal of Commercial Biotechnology

Multinational, United States

Pharmaceutical: Sales & Marketing Domain Supplement

North America, United Kingdom

Mitratech

United States

FDA, Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 (Rev. 2007)

FDA, Guidelines for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (2006)

FDA, Frequently Asked Questions on Drug Development and Investigational New Drug Applications

FDA, Computerized Systems Used In Clinical Investigations (2007)

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

HHS List of Excluded Individuals/Entities

FDA/CDER, Information for Clinical Investigators

FDA/CDER, Drug Approval Application Process

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

Solutions in pharma: Prescription for compliance (2005)

Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008)

HHS-IG Issues Drug Marketing Guidance To Industry (2002)

FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective, The (2002, 2005)

PBM Transparency May Only Be Skin Deep (2007)

IN VIVO Blog, The (Elsevier Business Intelligence)

Pharma Marketing News: Articles Library

Prescription Drug Marketing Act (PDMA) - Relevant Laws and Legislative History

False Claims Act

Federal Food, Drug, and Cosmetic Act

Prescription Drug Marketing Act of 1987

Public Health Service Act

Prescription Drug Amendments of 1992, Public Law 102-353

Prescription Drug Marketing (21 C. F. R. Part 203)

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

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

Drugs for Human Use (21 C.F.R. Part 300 et seq.)

Use of Educational Grants by Pharmaceutical Manufacturers (Senate Committee Report, 2007)

Financial Impacts of Waste, Fraud, and Abuse in Pharmaceutical Pricing (House of Representatives Hearing, Feb. 2007)

GAO, Prescription Drugs: Oversight of Drug Pricing in Federal Programs (2007)

Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals

Bristol-Myers Squibb : Compliance & Ethics

FDA, Newly Added Guidance Documents - Drugs

FDA, Import and Export Guidance Documents