Pharmaceutical

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OCEG Contributed

Life Sciences, Biotechnology and Pharma
PBM Transparency May Only Be Skin Deep (2007)
FDA, Frequently Asked Questions on Drug Development and Investigational New Drug Applications
FDA/CDER, Guidance Documents Page
Prescription Drug Marketing Act (PDMA) - Relevant Laws and Legislative History
FDA, Computerized Systems Used In Clinical Investigations (2007)
Pharma Marketing News: Articles Library
FDA, International Organizations and Foreign Government Agencies
Solutions in pharma: Prescription for compliance (2005)
Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008)
HHS/OIG Compliance Guidance
HHS-IG Issues Drug Marketing Guidance To Industry (2002)
PhRMA Code on Interactions with Healthcare Professionals (2008)
PhRMA's Marketing Code Touts Sarbanes/Oxley-esque Compliance Mechanism (2008)
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
Life Sciences Company Seeks Improved HR Service Delivery
OCEG for Technology
NIH, ClinicalTrials.gov
FDA Debarment List
HHS List of Excluded Individuals/Entities
Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals
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)
FDA, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (1996)
FDA/CDER, Information for Clinical Investigators
FDA/CDER, Drug Approval Application Process
FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective, The (2002, 2005)
Food and Drug Administration Amendments Act of 2007, Public Law 110–85
False Claims Act
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.)
Prescription Drug Advertising (21 C.F.R. Part 202 et seq.)
Drugs for Human Use (21 C.F.R. Part 300 et seq.)
Prescription Drug Amendments of 1992, Public Law 102-353
Pharmaceutical: Sales & Marketing Domain Supplement
FDA, Newly Added Guidance Documents - Drugs
Journal of Commercial Biotechnology
FDA, Import and Export Guidance Documents

Member Contributed

Bristol-Myers Squibb : Compliance & Ethics
IN VIVO Blog, The (Elsevier Business Intelligence)
FDA, Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 (Rev. 2007)
PharmAsia News
Japan, Pharmaceuticals and Medical Devices Agency (PMDA)
Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA)
FDA, Guidance for Industry: Pharmacogenomic Data Submissions — Companion Guidance (2007 Draft)
FDA, Guidelines for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (2006)
HHS/OIG, Compliance Program Guidance for Pharmaceutical Manufacturers (2003)
OIG Factsheet, Federal Anti-kickback Law and Regulatory Safe Harbors
PharmaLive.com
Fraud Risk Management in Life Sciences Companies (Deloitte, Rev. 2009)
Mitratech
BWise
SAS Institute, Inc.
Related communities
Life Sciences, Biotechnology and Pharma