All Topics — Highlights

How to Comply with Drug CGMPs, 2nd Edition

Softbound | 100 pages

FDCA Statutory Supplement, 2017

Softbound | 600 pages

21st Century Cures Act

Recorded December 21, 2016 | On-Demand Webinar

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

Recorded June 15, 2016 | On-Demand Webinar

All Programs
All Resources

All Topics — Programs

Introduction to U.S. Drug Law and Regulation

June 14-15, 2017 | Boston, MA

Advertising and Promotion Conference: For the Drug, Medical Device, and Veterinary Industries

September 26-27, 2017 | Washington, DC

Food and Drug Law Journal 2017 Symposium

October 20, 2017 | Washington, DC

Introduction to U.S. Tobacco Law and Regulation

October 25, 2017 | Washington, DC

Tobacco Products Regulation and Policy Conference

October 26-27, 2017 | Washington, DC

Drug Quality Security Act Conference

November 15, 2017 I Washington, DC

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

May 3-4, 2018 | Washington, DC

All Topics — Resources

FDA Looks at Improving Implementation of the Hatch-Waxman Amendments

Update EXTRA | July 27, 2016

Drugs and Biologics: New Administration, New Legislation, New Precedents

Update Magazine | May/June 2017

Momentum Builds for Medical Device Cybersecurity to Level Up

Update Magazine | May/June 2017

Food and Dietary Supplement Class Actions

Update Magazine | May/June 2017

Tobacco Deeming: One Year Later

Update Magazine | May/June 2017

FDA Inspections: The Changing Landscape

Update Magazine | May/June 2017

21st Century Cures Act Implementation

Update Magazine | May/June 2017

FDLI Annual: By the Numbers

Update Magazine | May/June 2017

Introduction to U.S. Drug Law and Regulation

June 14-15, 2017 | Boston, MA

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

FDCA Statutory Supplement, 2017

Softbound | 600 pages

What’s Missing from MDUFA IV?

October 31, 2016 | Food and Drug Policy Forum

How Will FDA Regulate Off-Label Communications in the Post-Facteau World?

September 26, 2016 | Food and Drug Policy Forum

Pure Powdered Caffeine: Stakeholders Take Measure of FDA’s Warning Letters

February 10, 2016 | 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

Bringing Your Medical Device to Market, 3rd Edition

Softbound | 450 Pages

All Topics — On Demand Webinars

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

Key Takeaways and Interactions between FSMA’s Final Rules

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