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

All Topics — Programs

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

May 3-4, 2018 | Washington, DC

Introduction to US Food Law and Regulation

Two Days in September 2018 | Washington, DC

Food Advertising, Labeling, and Litigation Conference

Two Days in September | Washington, DC

Introduction to US Biologics and Biosimilars Law and Regulation

October 3-4, 2018 | Washington, DC

Introduction to Advertising and Promotion

October 15, 2018 | Washington, DC
Register by July 19 and SAVE

Advertising and Promotion Conference

October 16-17, 2018 | Washington, DC
Register by July 19 and SAVE

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

Introduction to US Medical Device Law and Regulation

November 7-8, 2018 | Washington, DC

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

Enforcement, Litigation, and Compliance Conference

Two Days in December 2018 | Washington, DC

All Topics — Resources

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

Call for Proposals Form Page

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

Annual Materials

May 3-4, 2018 | Washington, DC

Agenda Test

Materials will be added as they become available.

Thursday, May 4

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

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