All Topics — Programs

Introduction to U.S. Drug Law and Regulation

June 14-15, 2017 | Boston, MA

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

Introduction to U.S. Drug Law and Regulation

November 2-3, 2017 | Washington, DC

Introduction to U.S. Medical Device Law and Regulation

November 2-3, 2017 | Washington, DC

Patient Organizations: An Introduction to U.S. Drug Law and Regulation

November 7-8 I Washington, DC

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

November 9, 2017 | Live Webinar

Drug Quality Security Act Conference

November 15, 2017 I Washington, DC

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

November 16, 2017 | Live Webinar

FDLI Annual Holiday Member Reception

December 6, 2017 | Washington, DC

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

May 3-4, 2018 | Washington, DC

All Topics — Resources

“Consistent Communications”: FDA’s Incremental Expansion of Promotional Bounds

Update Magazine | July/August 2017

Sales Reps in the OR: Best Practices for Medical Device Manufacturers

Update Magazine | July/August 2017

Process Labeling: The Challenges of Transparency

Update Magazine | July/August 2017

California Trial Court Cuts Plaintiffs’ Bait in Tuna Misbranding Suit

Update Magazine | July/August 2017

Case Note: Sandoz v. Amgen

Update Magazine | July/August 2017

FDA Sharpens its Focus on Regenerative Medicine Regulation

Update Magazine | July/August 2017

Spotlight on Tobacco: A Model Risk Continuum for Tobacco and Nicotine Products

Update Magazine | July/August 2017

Remarks by Acting FDA Commissioner Stephen M. Ostroff, MD

Food and Drug Law Journal | Volume 72 | Number 3

Communicating Tobacco Product Information to the Public

Food and Drug Law Journal | Volume 72 | Number 3

The Role of Patient Participation in Drug Approvals: Lessons from the Accelerated Approval of Eteplirsen

Food and Drug Law Journal | Volume 72 | Number 3

Assessing the Scientific Basis of the Agricultural Water Provision of the FSMA Produce Safety Rule

Food and Drug Law Journal | Volume 72 | Number 3

European Novel Foods Policy at a Critical Juncture

Food and Drug Law Journal | Volume 72 | Number 3

The Compounding Conundrum

Food and Drug Law Journal | Volume 72 | Number 3

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

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

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