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COVID Academic Interest Form

Requesting Complimentary Access to FDLI’s COVID Intro Course

To request complimentary access to FDLI’s virtual course, COVID-19: Introduction to FDA’s Legal Authorities and Emerging Issues, please complete the following form.

Once your request is approved, you will […]

Intro to COVID-19: Drug Issues

Intro to COVID-19: Drug Issues

This session will address a variety of issues relevant to the drug space, including current authorizations, conditions for authorization, supply chain challenges and shortages, the Coronavirus Treatment Acceleration Program […]

Intro to COVID-19: Diagnostics and Laboratory Testing

Intro to COVID-19: Diagnostics and Laboratory Testing

This session will cover emerging issues in diagnostics and laboratory testing, including emergency use authorization declarations for diagnostics, overview of testing types, and enforcement and PREP Act […]

Intro to COVID-19: Combating Fraudulent Products

Intro to COVID-19: Combating Fraudulent Products

This session will discuss the varying authorities FDA has to combat fraudulent products including warning letters, seizures, injunctions, and criminal prosecutions.

Cathy L. Burgess , Partner, Alston & Bird […]

Intro to COVID-19: Personal Protection Equipment (PPE)

Intro to COVID-19: Personal Protection Equipment (PPE)

This session will address the agencies involved in the regulation of Personal Protective Equipment (PPE) and their respective roles.

Sung W. Park Associate, Reed Smith LLP

This session was […]

Intro to COVID-19: Ventilators and 3D Printed Devices

Intro to COVID-19: Ventilators and 3D Printed Devices

This session will discuss emerging legal issues related to ventilators and 3D printed devices, including FDA enforcement policies and emergency use authorizations.

Benjamin Wolf , Senior Associate, […]

Naming of Chiral Drugs: Should We Revisit?

Naming of Chiral Drugs: Should We Revisit?

Mahsa Salsabili, Claire Caschetta, Nicholas Senne & Stephen Schondelmeyer

ABSTRACT

The purpose of standard nonproprietary, or generic, drug nomenclature is to provide a universally consistent and reliable name that facilitates safe […]

Formal Dispute Resolution and the Food and Drug Administration

Formal Dispute Resolution and the Food and Drug Administration

Marlan Golden

ABSTRACT

Although appeals of federal administrative agency action receive considerable attention, appeals within administrative agencies are seldom discussed. This Article focuses on FDA’s internal processes for appeals […]

Regulation of Over-the-Counter (OTC) Drugs: An Introduction

Regulation of Over-the-Counter (OTC) Drugs: An Introduction

Compare prescription drug and OTC drug categories. Review the recently revised OTC Monograph process and discuss Rx-to-OTC switches.

Carolina Wirth , Of Counsel, Arnall Golden Gregory LLP
Genevieve M. […]

Post Marketing Issues for Medical Devices: An Introduction

Post Marketing Issues for Medical Devices: An Introduction

Review the definitions and purposes of complaint handling, Medical Device Reporting (MDR), recalls, corrections and removals, safety alerts, and ongoing monitoring/ postmarket surveillance. Examine risk communication initiatives.

Marc […]

Overview of Medical Device Law and Regulation

Overview of Medical Device Law and Regulation

Review the statutory framework of how the government regulates the medical device industry. Define “device” and differentiate between the medical device classes. Explore the nuances of combination […]

Biologics License Applications (BLA): An Introduction

Biologics License Applications (BLA): An Introduction

Assess historical and current standards of approval. Discuss what standard FDA uses to approve a BLA submitted under section 351(a) of the Public Health Service Act (PHSA). Outline what […]

The Regulation of Biological Product Manufacturing: An Introduction

The Regulation of Biological Product Manufacturing: An Introduction

Examine guidelines for establishment registration and listing. Review standards forf inspections, how to determine when a product is considered adulterated, and current Good Manufacturing practices (cGMPs). Discuss […]

An Introduction to Biosimilar Product Regulation and Approval

An Introduction to Biosimilar Product Regulation and Approval

Review background and definitions of biologic and biosimilar drugs and new drug application (NDAs) and biologics license application (BLAs). Discuss biosimilar pathways to market and application contents. […]

Regenerative Medicine and Advanced Therapies: An Introduction

Regenerative Medicine and Advanced Therapies: An Introduction

Distinguish between human cellular and tissue-based products (HCT/P). Review the regulatory framework for the regulation of regenerative medicine products and discuss key definitions and eligible therapies. Examine expedited […]

Regulation of Biological/Drug Development: An Introduction

Regulation of Biological/Drug Development: An Introduction

Examine preclinical and clinical testing, sources of Good Clinical Practice (GCP) requirements and phases of the clinical trial process. Assess the obligations of sponsors and investigators. Discuss how to […]

Regulation of Drug Marketing: An Introduction

Regulation of Drug Marketing: An Introduction

Review the scope of FDA authority of drug promotion and advertising. Define “label” and “labeling” and “false and “misleading”. Gain insight on FDA’s social media guidance, use of off-label […]

Regulation of Drug Manufacturing: An Introduction

Regulation of Drug Manufacturing: An Introduction

Examine Current Good Manufacturing Practices (cGMPs) for drugs and define “adulteration” and “misbranding”. Review the different types of inspections, including the differences between foreign and domestic inspections. Explore the […]

The Regulation of Biologics and Biosimilars: An Introduction

The Regulation of Biologics and Biosimilars: An Introduction

Define biosimilars. Discuss the approval standards of Biologics License Applications (BLAs). Explore exclusivity issues and the “Patent Dance”.

Suchira Ghosh , Of Counsel, Hyman, Phelps & McNamara, PC

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New, Emerging, and Continually Interesting Issues

New, Emerging, and Continually Interesting Issues

Discuss emerging issues in transitional biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference […]

The New Drug Approval Process: Basic Concepts

 The New Drug Approval Process: Basic Concepts

Define what is a drug and differentiate a drug from a, biologic, food, dietary supplement, medical device, cosmetic, or combination products. Explore legal standards for approval of […]

The Regulation of Dietary Supplements: An Introduction

The Regulation of Dietary Supplements: An Introduction

Recognize what is a dietary supplement and examine statements of nutritional support and structure function claims. Summarize dietary supplement safety, Serious Adverse Event Reporting (SAER) requirements, and Good […]

The Regulation of Cosmetics: An Introduction

The Regulation of Cosmetics: An Introduction

Examine how cosmetics are regulated. Define “cosmetic” and “color additives”. Evaluate cosmetics vs. drugs and/or devices. Explore cosmetic labeling and warning requirements.

Ann M. Begley , Partner, Morgan, Lewis & […]

The Regulation of Biological Product Marketing: An Introduction

The Regulation of Biological Product Marketing: An Introduction

Discuss the legal and regulatory requirements surrounding communications about biologics and biosimilars. Examine the definitions of misbranding, label and labeling, and off-label promotion. Explore the basic rules […]

Regenerative Medicine Conference Keynote

Regenerative Medicine: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies

Keynote Address | April 2, 2020

During the COVID-19 crisis, FDLI is dedicated to serving as an educational resource for our valued members. […]

2020 Food Enforcement Agenda

Why Attend

Agenda

CLE

Thursday, March 26


8:50 – 9:00 AM
Welcome and Opening Remarks
Amy Comstock Rick, President & CEO, FDLI
Laura Brown, Director, Educational Programs, […]

Awards Test

Join your fellow FDLI members to celebrate the holiday season, and mix and mingle with the food and drug law community!

The reception is complimentary for FDLI members.  Advanced registration is required.

At the JW […]

The 505(b)(2) Drug Approval Pathway

The 505(b)(2) Drug Approval Pathway

Jonathan J. Darrow, Mengdong He & Kristina Stefanini

Abstract

Codified in 1984, the Section 505(b)(2) drug approval pathway lies part-way between the regular new drug approval pathway and the generic drug approval pathway, […]

Annual Agenda 2019

Why Attend

Agenda

Location & CLE

Thursday, May 2

8:00 – 9:00 AM | Registration and Continental Breakfast | ATRIUM

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