Topics 2017-11-19T22:00:41+00:00

All Topics — Programs

Cell-Based Meat and Other Modified Foods

Regulatory Concerns and Potential Pathways Forward
June 26, 2018 | 2:00-3:30 PM ET | Live Webinar

Guidance on Guidance: FDA, DOJ, and Enforcement

July 12, 2018 | 2:00 - 3:00 pm ET | Live Webinar

Center for Devices and Radiological Health: What’s Ahead for 2018 and Beyond

Panel Discussion and Networking Reception
July 17, 2018 | Boston, MA

Introduction to US Drug Law and Regulation

July 24-25, 2018 | South San Francisco, CA
Register by June 21 and SAVE

FDA’s Digital Health Innovation Action Plan – Key Updates

Panel Discussion and Networking Reception
July 25, 2018 | South San Francisco, CA

Introduction to US Medical Device Law and Regulation

July 26-27, 2018 | South San Francisco, CA
Register by June 21 and SAVE

Introduction to US Food Law and Regulation

September 24-25, 2018 | Washington, DC
Register by August 21 and SAVE

Food Advertising, Labeling, and Litigation Conference

For the Food and Dietary Supplement Industries
September 26-27, 2018 | Washington, DC
Register by August 21 and SAVE

Introduction to US Biologics and Biosimilars Law and Regulation

October 3-4, 2018 | Washington, DC
Register by September 6 and SAVE

Introduction to Advertising and Promotion

For the Drug, Medical Device, and Veterinary Industries
October 15, 2018 | Washington, DC
Register by July 19 and SAVE

Advertising and Promotion Conference

For the Drug, Medical Device, and Veterinary Industries
October 16-17, 2018 | Washington, DC
Register by July 19 and SAVE

FDA: Past, Present, and Future

October 19, 2018 | Washington, DC

Introduction to US Tobacco Law and Regulation

October 24, 2018 | Washington, DC
Register by August 23 and SAVE

Tobacco Products Regulation and Policy Conference

October 25-26, 2018 | Washington, DC
Register by August 23 and SAVE

Food and Drug Law Journal 2018 Symposium

November 2, 2018 | Washington, DC

Introduction to US Drug Law and Regulation

November 7-8, 2018 | Washington, DC
Register by October 4 and SAVE

Introduction to US Medical Device Law and Regulation

November 7-8, 2018 | Washington, DC
Register by October 4 and SAVE

Enforcement, Litigation, and Compliance Conference

For the Drug, Device, Food and Tobacco Industries
December 12-13, 2018 | Washington, DC
Register by October 18 and SAVE

FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law

May 2-3, 2019 | Washington, DC
Register by February 7 and SAVE

All Topics — Resources

Organic Chemistry for the Food and Drug Community

Recorded June 21, 2018 | On-Demand Webinar

Implementing a Public Health Perspective in FDA Drug Regulation

Implementing a Public Health Perspective in FDA Drug Regulation

Patricia J. Zettler, Margaret Foster Riley, and Aaron S. Kesselheim

ABSTRACT

There is, without question, a public health crisis in the United States arising from both illicit […]

Off-Label Communications: The Prodigal Returns

Off-Label Communications: The Prodigal Returns

Jeffery Chasnow and Geoffrey Levitt

INTRODUCTION

Recent changes in law and policies relating to “off-label” product communications by manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son.1 In the parable, […]

Should FDA Try to Move Smokers to E-Cigarettes and Other Less Harmful Tobacco Products and, If So, How?

Should FDA Try to Move Smokers to E-Cigarettes and Other Less-Harmful Tobacco Products and, If So, How?

Eric N. Lindblom

ABSTRACT

The emergence of e-cigarettes has produced major changes in the tobacco industry and to adult and youth […]

“Natural” Food Claims: Industry Practices, Consumer Expectations, and Class Action Lawsuits

“Natural” Food Claims: Industry Practices, Consumer Expectations, and Class Action Lawsuits

Neal Hooker, Christopher T. Simons, and Efthimios Parasidis

ABSTRACT

This article examines industry practices, consumer expectations, and class action lawsuits involving natural food claims. Although anecdotal evidence […]

Agribusiness and Antibiotics: A Market-Based Solution

Student Note
Agribusiness and Antibiotics: A Market-Based Solution

Allison Parr

ABSTRACT

Justifiable concerns about the welfare of animals raised for food are on the rise in the United States.1 The model of modern agribusiness aims at maximizing costefficiency, […]

What’s New at FDA for Medical Products and Foods?

Update Magazine | March/April 2018

FDA’s Tools to Respond to Public Health Emergencies

Update Magazine | March/April 2018

FDA Data Integrity Enforcement Trends and Practical Mitigation Measures

Update Magazine | March/April 2018

FDA Plan for Tobacco and Nicotine Regulation

Update Magazine | March/April 2018

Protecting Trade Secrets in the Medical Product Approval Process

Update Magazine | March/April 2018

China: Breaking Down the “Great Wall”?

Update Magazine | March/April 2018

Top 10 Updates on Canadian Market Access, Exclusivity, and Pricing Issues

Update Magazine | March/April 2018

Data Integrity: FDA Enforcement and Risk-Reduction Considerations

Recorded March 13, 2018 | On-Demand Webinar

What’s in a Name? Sometimes, a Claim

Update Magazine | January/February 2018

Laws and Regulations Concerning Cell-Cultured Meat and Cellular Agriculture

Update Magazine | January/February 2018

Navigating an FTC Drug Pricing Investigation

Update Magazine | January/February 2018

Eye on Enforcement

Update Magazine | January/February 2018

5th Annual Blumberg Lecture

Update Magazine | January/February 2018

Genomic Malpractice: An Emerging Tide or Gentle Ripple?

Food and Drug Law Journal | Volume 72 | Number 4

Step Therapy: Legal, Ethical, and Policy Implications of a Cost-Cutting Measure

Food and Drug Law Journal | Volume 73 | Number 1

Changing Our Minds: Reforming the FDA Medical Device Reclassification Process

Food and Drug Law Journal | Volume 73 | Number 1

First Amendment Issues in Advertising and Product Packaging Webinar

Recorded February 13, 2018 | On-Demand Webinar

FDCA Statutory Supplement, 2018

Softbound | 660 pages

Food Litigation Trends: New and Undefined Label Claims in 2017

Update Magazine | November/December 2017

Inaugural Wiet Life Science Law Scholars Conference

Update Magazine | November/December 2017

Capturing Postmarket Benefits in Device Compliance and Enforcement

Update Magazine | November/December 2017

Those Involved in Compound Pharmaceuticals Beware: Law Enforcement Is Focused on You

Update Magazine | November/December 2017

Kid Tested, FDA Approved: Examining Pediatric Drug Testing

Food and Drug Law Journal | Volume 72 | Number 4

Get Real: Organic Marketing Under USDA’s Proposed Promotion & Research Agreement

Food and Drug Law Journal | Volume 72 | Number 4

What Happens When FDA Delays a Rule? Menu Labeling as a Case Study

Update Magazine | November/December 2017

When the Alpha is the Omega: P-Values, “Substantial Evidence,” and the 0.05 Standard at FDA

Food and Drug Law Journal | Volume 72 | Number 4

The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls

Update Magazine | September/October 2017

Brand Name Preemption: The New Frontier In Pharmaceutical Product Liability Litigation

Food and Drug Law Journal | Volume 72 | Number 4

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI

Update Magazine | November/December 2017

Letter to the Editor

Food and Drug Law Journal | Volume 72 | Number 4

How Can FDA Address the Opioid Addiction Crisis?

Update EXTRA | October 27, 2017

How to Comply with Drug CGMPs, 2nd Edition

Softbound | 100 pages

High Time for the Supreme Court to Review Ascertainability in Class Actions

April 18, 2017 | Food and Drug Policy Forum

Guide to U.S. Import Requirements for Cosmetics and Other Personal Care Products

FDLI Primer | Downloadable PDF

Bringing Your Pharmaceutical Drug to Market

Softcover | 800 Pages

Food and Drug Law and Regulation, 3rd Edition

Hardbound | 995 Pages

All Topics — On Demand Webinars

Organic Chemistry for the Food and Drug Community

Recorded June 21, 2018 | On-Demand Webinar

USDA’s Proposed Bioengineered Food Disclosure Standard

Key Issues and Next Steps
Recorded June 14, 2018 | On-Demand Webinar

DEA Law for the Food and Drug Community

Recorded May 30, 2018 | On-Demand Webinar

Data Integrity: FDA Enforcement and Risk-Reduction Considerations

Recorded March 13, 2018 | On-Demand Webinar

First Amendment Issues in Advertising and Product Packaging Webinar

Recorded February 13, 2018 | On-Demand Webinar

Real World Evidence: Data Requirements, Utilization, and Presentation

Recorded December 1, 2017 | On-Demand Webinar

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for Industry

Recorded November 29, 2017 | On-Demand Webinar

Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights

Recorded November 17, 2017 | On-Demand Webinar

FDA, USDA, and EPA: Inter-Agency Overlap and Jurisdictional Boundaries

Recorded November 9, 2017 | On-Demand Webinar

PDUFA and BsUFA Reauthorization: Key Changes Affecting Industry and Patients

Recorded September 12, 2017 | On-Demand Webinar

Key Regulatory Issues in Biosimilars

Recorded August 9, 2017 | On-Demand Webinar

Regulation of Cannabis in FDA-Regulated Products

Recorded July 19, 2017 | On-Demand Webinar

The EU’s New Medical Device and IVD Regulations

Recorded June 7, 2017 | On-Demand Webinar

REMS: Key Issues and Best Practices

Recorded May 23, 2017 | On-Demand Webinar

Compounding Still in the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later

Recorded May 18, 2017 | On-Demand Webinar

False Claims Act Enforcement

Recorded April 4, 2017 | On-Demand Webinar

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

Recorded March 16, 2017 | On-Demand Webinar

21st Century Cures Act

Recorded December 21, 2016 | On-Demand Webinar

The Yates Memo: A Lawyer’s Professional Responsibility

Recorded December 14, 2016 | On-Demand Webinar

Social Media: Innovative Uses and Practical Experiences

Recorded November 17, 2016 | On-Demand Webinar

Mandatory GMO Labeling: Preparing for Implementation

Recorded August 31, 2016 | On-Demand Webinar

New FDA Nutrition Facts Label: Implications for Industry

Recorded June 29, 2016 | On-Demand Webinar

A First Look at the Deeming Regulations: A Two-Part Webinar

Recorded June 15, 2016 | On-Demand Webinar

New Changes to California’s Prop 65: What Do They Mean for You?

Recorded April 21, 2016 | On-Demand Webinar

Open Payments Data and the Sunshine Act: Managing the Risk of Transparency

Recorded March 14, 2016 | On-Demand Webinar

Marijuana Regulation in the Food and Drug Realm

Recorded February 12, 2016 | On-Demand Webinar

Medical Foods Regulation

Recorded February 12, 2016 | On-Demand Webinar