Join FDLI to learn the essentials of drug and device law and how to engage with FDA to better support your organization’s advocacy efforts.

For this two-day program, FDLI brings together law, industry, and FDA experts with deep advocacy experience to equip patient organizations with an understanding of the legal framework and strategies available for interacting with the agency. Case studies will illustrate the opportunities for engagement and legal challenges facing, patient organizations, industry, and the FDA.

Agenda Highlights Include:

  • New Drug Development and Clinical Trials Regulation
  • Submission of Marketing Applications and the FDA Approval Process
  • Expanded Access
  • Implementation of the 21st Century Cures Act
  • New Device Development
  • The 510(k) Process and De Novo Review for Devices
  • Interacting with Drug and Device Development Industries and FDA

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This course is offered for staff and volunteers of 501(c)3 patient or disease organizations. Applications are considered on a case by case basis.

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Preliminary Agenda

Tuesday, November 5

8:15 – 8:45 AM
Registration and Continental Breakfast

8:45 – 9:00 AM
Welcome and Announcements

9:00 – 10:00 AM
Introduction to FDA and Other Agencies

  • The U.S. Drug Regulatory Process
  • FDA Organization
  • Types of FDA Regulatory Requirements and Pronouncements
  • Congressional Oversight
  • The FDA’s Relationship with Other Agencies

10:00 – 11:00 AM
New Drug Development Under an Investigational New Drug Application (IND)

  • What is a “Drug”?
  • What is a “New Drug”?
  • Other Drug-Like Products
  • Who Decides Whether a Product is a “New Drug”?
  • The IND Process
  • IND Application

11:00 – 11:15 PM
Networking Break

 11:15 AM – 12:45 PM

Approval and Clearance Pathways for Medical Devices

  • What is a “Device”?
  • Medical Device Amendments of 1976
  • Predicate Devices and Substantial Equivalence
  • Who Decides Whether a Device Needs Premarket Approval (PMA) or a 510(k) Clearance?
  • Laboratory-Developed Tests and In-Vitro Diagnostics
  • De Novo Requests for Classification

 12:45 – 1:30 PM
Luncheon

1:30 – 3:00 PM
The FDA Approval Process for Drugs

  • Submission & Filing of NDAs/BLAs
  • Approval Standards
  • The Review Process
  • Expedited Review

3:00 3:15 PM
Networking Break

3:15 – 4:15 PM
Conduct of Clinical Trials for Drugs and Medical Devices and Human Subjects Protections

  • Clinical Testing/Investigation and “Good Clinical Practice” (GCP)
  • Clinical Trials Registration and Results Reporting (clinicaltrials.gov)
  • Human Subjects Research Protection
  • Bioresearch Monitoring (BIMO)
  • Investigational Device Exemptions
  • Adverse Event Reporting

4:15 – 5:00 PM
Stakeholder Interactions in the Drug Development Community

  • Sponsor-Patient Group Engagement
  • Payor Communications Post-Cures Act

5:00 – 6:00 PM
Reception

Wednesday, November 6

8:30 – 9:00 AM
Continental Breakfast

9:00 – 10:00 AM
Expanded Access to Investigational Therapies for Drugs and Medical Devices

  • Expanded Access
  • Federal Right-to-Try Legislation and Effect on Current FDA Expanded Access Framework

10:00 – 11:00 AM
Post-Approval Obligations of Drug Companies

  • Post-Approval (“Phase IV”) Investigations
  • Withdrawal of Approval
  • Annual Reports
  • Adverse Drug Experience (ADE) Reports
  • Post-Approval Changes and Supplemental NDAs (sNDAs) and ANDAs
  • Grounds for Withdrawal of Approval
  • Sale/Transfer of NDAs/ANDAs
  • Post-Approval Safety Issues
  • Product Quality Considerations
  • Unapproved Uses of Drugs

11:00 – 11:15 AM
Networking Break

11:15 AM – 12:15 PM
Post-Marketing Issues for Medical Device Companies

  • Adverse Event Reporting Procedures
  • Product Recalls
  • Product Servicing and Refurbishing
  • Unique Device Identifiers
  • Safety Alerts and Physician Communication
  • Ongoing Monitoring of Device Performance and Conditions of a PMA

12:15 – 1:00 PM
Luncheon

1:00 – 2:00 PM
Hatch-Waxman and Other Statutory Incentives

  • Patent Term Restoration/Extension
  • Five- and Three-Year Exclusivity
  • 180-Day Exclusivity
  • Pediatric Exclusivity
  • Orphan Drugs
  • Priority Review Vouchers (PRVs) (Tropical Disease, Rare Pediatric Disease, and Medical Countermeasures)
  • Biosimilars: Intersection of Regulatory Exclusivity and Patent Exclusivity

2:00 – 2:15 PM  
Networking Break

2:15 – 3:15 PM
Engaging with FDA: Opportunities and Boundaries

  • FDA’s Patient Engagement Offices
  • FDA’s Patient Engagement Programs
  • Participating in FDA Policymaking

3:15 – 4:00 PM
Tying it All Together: Engaging with FDA to Improve Advocacy Outcomes
This session will highlight relevant case studies of how effective advocacy and utilizing the knowledge gained from this course can have an impact on FDA policymaking.

4:00 PM
Adjournment

A special thanks to the FDLI Patient Organization Engagement Committee:

Ryan Hohman, Friends of Cancer Research
Brenda Huneycutt, FasterCures
Debra Lappin, Faegre Baker Daniels Consulting
James Valentine, Hyman, Phelps & McNamara, PC
Laura Wingate, Crohn’s & Colitis Foundation

Location

Milken Institute School of Public Health
At the George Washington University
950 New Hampshire Ave, NW
Washington, DC 20052

Public Transportation

The Milken Institute SPH building at Foggy Bottom is easily accessible by MetrorailMetrobus and commuter buses from Maryland and Virginia. The nearest Metrorail station is Foggy Bottom – GWU (Blue, Silver and Orange Lines), located one block away on 23rd and Eye Street, NW. View more public transportation options.

 

Parking

View campus parking options.
In Foggy Bottom, there are several private parking garages near the school. Street parking is limited, and parking garages can be expensive.

Please contact  Hayden Galante with any accessibility requirements or dietary restrictions, or for other questions.