Chapter One
FDA report FDA Innovation – Stagnation
FDA report Pharmaceutical cGMPs for the 21st Century – Risk-Based Approach
FDA CDRH presentation Personalized Medicine – View from OIVD
*bonus download
FDA CDER presentation Risk-Benefit Consideration for New Drugs
*bonus download
HHS announcement on the intent to formalize the FDA-CMS collaboration
*bonus download
Chapter Two
GAO report 07-49 New Drug Development
FDA guidance CGMP for Phase 1 Investigational Drugs
FDA guidance Current Good Manufacture Practice for Combination Products (links to FDA page)
ICH Q8 guideline Pharmaceutical Development
ICH M3 guideline Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
Chapter Three
FDA guidance Quality Systems Approach to Pharmaceutical CGMP Regulations
SmarterCompliance Defensible Documents (SOP) Template (see templates also)
FDA guidance Establishment and Operation of Clinical Trial Data Monitoring Committees
Chapter Four
FDA CDER presentation Regulatory Considerations for Nanotechnology Products
FDA report Nanotechnology: A Report of the US FDA Nanotechnology Task Force
*bonus download
Cerulean report FDA Enforcement Trends 2008-2009
Cerulean report Ten Ways to Control Your Compliance Costs
Article: Virtual Consultants – Are They for You?
FDA guidance Radio-Frequency Wireless Technology in Medical Devices
FDA report Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications
Chapter Five
Case Study: Can Compliance Help Marketing and Business Development?
Prelec’s Readings Packet on the Information Pump
Prelec’s The Information Pump Game
SmarterCompliance Product Concept Summary Template (see templates also)
FDA guidance Label Comprehension Studies for Nonprescription Drug Products
FDA guidance Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
SmarterCompliance Intellectual Property Security Self-Assessment Checklist
Article: Target Therapy Database: A Model to Match Patient’s Molecular Profile with Current Knowledge on Cancer Biology *bonus download
Chapter Six
Presentation slides on quality by design preliminary client results
FDA guidance Q8 Pharmaceutical Development Revision 1
FDA guidance PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
Chapter Seven
OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Cerulean 5-Slide Overview of FDA’s Quality System Regulations (see mini-seminars also)
FDA guidance Hazard Analysis and Critical Control Point Principles and Application Guidelines (links to FDA page)
ICH Q10 guideline Pharmaceutical Quality System
Chapter Eight
FDA guidance Exploratory IND Studies
FDA guidance End-of-Phase 2A Meetings
FDA report Strategic Plan for Risk Communication
Cerulean Compliance Alert on Risk Communication
*bonus download
FDA guidance Adaptive Clinical Trial Design for Drugs and Biologics
*bonus download
Article: Export Compliance for Life Sciences
Chapter Nine
SmarterCompliance 27-Point Records Management and Control Checklist
Article: How to Meet Compliance and Records Requirements of the US FDA
Article: Getting the Results You Expect from Consultants
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