Course Description:

The Food and Drug Administration (FDA) regulates medical products under several Federal laws, a myriad of regulations and many organizational units. The Federal Food, Drug and Cosmetic Act is a criminal statute that subjects the most senior corporate officials to liability under the “Park Doctrine”, even if they were unaware of the existence of their company’s problems.

What a medical product is considered to be by FDA can be the single most important the decision the Agency can make. How it will be regulated under the Federal Food, Drug, Cosmetic or Public Health Service Acts will determine the path (and speed) to market, what submissions will be required, and requirements after clearance or approval.

This seminar will discuss how product jurisdiction is determined by FDA under laws, regulations, guidance and even traditions. Various definitions and precedents will be discussed. Actual and hypothetical case studies in large group and workshop format settings will provide the critical thinking skills needed to understand the regulatory environment.

After an overview of the statutes and regulations for drugs, devices, biologics and combinations are discussed, three major subjects will be covered;

  1. Clinical trials and pre market approvals
  2. Current Good Manufacturing Practices/Quality System Regulation (cGMP/QSR)
  3. Post marketing requirements. Techniques and sources to remain current will be provided

Learning Objectives:

  • The statutory and regulatory framework for FDA regulation of medical products, including FDA's organization
  • The path to market for drugs, devices, biologics and combination products, including generics and biosimilars
  • Clinical trials and bioresearch monitoring (BiMo)
  • The impact of user fees - old ones such as PDUFA and MDUFA, and new ones, such as GDUFA and BSUFA
  • FDA inspection and compliance policies and procedures for medical products
  • Manufacturing practices and quality regulation - cGMPs and QSR
  • Considerations and requirements after a product is marketed
  • Sources for FDA regulatory information

Who will Benefit:

Senior Management, staff new to an environment regulated by FDA, and those in industries allied to medical products, including:

  • Corporate, Division and Site Executives and Managers
  • Regulatory Affairs
  • Medical Affairs
  • Legal Staff
  • Quality and Audit Personnel
  • Investment Professions Covering Medical Products
  • ANYONE with a need for an overview of the FDA Regulation of Medical Products

Course Outline:

Day One     Day Two
  1. FDA Regulation of Medical Products
    1. The statutory and regulatory framework
      1. Drugs, Devices, Biologics and Combination Products
        1. The Federal Food, Drug Cosmetic Act
        2. The Public Health Service Act
      2. FDA Organization
        1. CBER
        2. CDER
        3. CDRH
        4. Other FDA components including the Offices of Regulatory Affairs and Combination Products
    2. Paths to Market
      1. Drugs
      2. Biologics
      3. Devices
      4. Generics
      5. Biosimilars
      6. User Fees
    3. Workshop – Case Studies
  2. Clinical Data and Bioresearch Monitoring
    1. Patient Protection
    2. Good Clinical Practices
    3. Good Laboratory Practices
    4. The FDA Bioresearch Monitoring Program
  3. Current Good Manufacturing Practices/Quality System Regulation
    1. GMP/QSR Evolution – “No Margin for Error”
    2. GMPs for the 21st Century/Quality System Approach
    3. Workshop – Case Studies

  1. Inspections, Compliance, Enforcement
    1. Inspection Policies and Procedures
    2. Preparing for an Inspection
    3. Inspection follow-up
    4. Compliance Policies and Procedures
    5. Enforcement Policies and Procedures including management criminal liability under the “Park Doctrine”.
  2. Post Marketing Requirements
    1. MedWatch
    2. VAERS
    3. Commitments
    4. Complaints
    5. Labeling, Advertising, Promotion
  3. Keeping Current
    1. The FDA Web Site
    2. Other Information Sources and Apps

Meet Your Instructor

Mark Elengold
President, FDA Strategies LLC

Mark A. Elengold is President of FDA Strategies LLC, which provides consulting services to FDA regulated industry and the financial community. He retired as the Deputy Director of the FDA’s Center for Biologics Evaluation and Research, after thirty-four years of service. He is an expert and frequent speaker on regulatory and compliance activities, Good Manufacturing Practices (GMPs), and FDA application review procedures, including electronic submissions.

After receiving a B.A. from Queens College of the City University of New York in 1971, he served as an FDA investigator in the New York District Office and the White Plains Resident Post. Prior to joining CBER in December, 1988, he held various positions in the Center for Drug Evaluation and Research, the Bureau of Veterinary Medicine and the Office of the Commissioner.

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