Course Detail

This course will examine operational, strategic and commercial aspects of the regulatory approval process for new drugs, biologics, devices and combination products in the United States.  The topics are designed to provide a chronological overview of the requirements needed to seek marketing approval.  Strategic, regulatory intelligence, risk management and marketing considerations are addressed throughout the course.  The U.S. regulatory requirements will be examined and analyzed as a candidate product is advanced from the Research and Development stage, through pre-clinical and clinical testing, to marketing approval, product launch and post-marketing phase.  The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in pharmaceutical, biotechnology or medical device industry.  Case studies from industry will be examined to supplement certain topics and to illustrate interpretation of regulations.

Required Text

Mark, Mathieu (2005) New Drug Development: A Regulatory Overview, Seventh Edition, PAREXEL International Corporation, Waltham, MA

Kahan, Jonathan, (2005) Medical Device Development: A Regulaotry Overview, PAREXEL International Corporation. Waltham, MA

• Food and drug laws, History of the FDA, Introduction to the FDA and the Drug approval process in the U.S., Center for Drug Evaluation and Research (CDER)
• Chemistry, Manufacturing and Controls (Quality), Common Technical Document (CTD) cGMP, Standard Operating Procedures (SOPs), Specifications, Drug Master Files (DMF), FDA warning letters
• Pre-clinical drug testing and Good Laboratory Practice (GLP)
• Investigational New Drug Application (IND) and the IND review process
• Clinical development of new drugs, Good Clinical Practices (GCP), Phases 1-3 studies, Adverse events
• New Drug Application (NDA)and Abbreviated NDA (ANDA)
• NDA review process, Action letters and Pre-Approval Inspections (PAI)
• Interacting with FDA
• Advisory committees
• Labeling, Packaging and Advertising
• Post marketing requirements, Supplemental NDA and Post-approval changes, Phase 4 studies
• Pharmacovigilance
• Orphan drug development program, Accelerated drug approvals, Accessibility programs
• Regulatory Intelligence, Product Precedence
• History of Medical Device Regulation
• Human Factors & Medical Device Errors
• Medical Device 510(k) and Pre-Market Approval (PMA) submissions
• Medical Device Good Manufacturing Practices
• Medical Device Payment Issues, including Medicare Reimbursement
• Combination Product Regulation

• A fundamental knowledge of the acronyms and terminology that are used in the U.S. Food & Drug Administration’s (FDA) regulatory approval process from the Investigational New Drug (IND) stage through submission and review of the Biologics License Application (BLA) or New Drug Application (NDA) and post market approval requirements for a new drug or biologic.
• A fundamental knowledge of acronyms and terminology that are used in the FDA regulatory approval process from the design input stage through submission and review of the 510(k) or Pre-Market Approval documentation and post market approval requirements for a new device.
• Comprehension of the documentation and regulatory requirements necessary at each stage of the U.S. regulatory submission and review process.
• Experience writing or revising a current Good Manufacturing Practice (cGMP) document for either a master batch record (MBR) or a standard operating procedure (SOP).
• Familiarity researching and interpreting FDA documentation including 483 letters, consent decrees and correspondence from DDMAC related to drug advertising.

Classroom attendance and participation, presentation of current events (drugs), discussion of preassigned readings (devices)15%

Written assignments (cGMP documentation: MBR or SOP,Human Factors Analysis) 30%

Presentation: Evaluation on IOM report on Future of Drug Safety 15%

Weekly quizzes 12 given, grade based on scores for top10 quizzes 40%