All Topics — Highlights

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

May 4-5, 2017 | Washington, DC

How to Comply with Drug CGMPs, 2nd Edition

Softbound | 100 pages

FDCA Statutory Supplement, 2017

Softbound | 600 pages

21st Century Cures Act

December 21, 2016 | On-Demand Webinar

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

June 15, 2016 | On-Demand Webinar

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All Topics — Programs

New to Food and Drug Law Group: Promotional Review Committees

April 25, 2017 | Washington, DC

Introduction to U.S. Drug Law and Regulation

April 26-27, 2017 | Washington, DC

Introduction to U.S. Medical Device Law and Regulation

April 26-27, 2017 | Washington, DC

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

May 4-5, 2017 | Washington, DC

Compounding Still in the Mix: The DSCSA Three Years Later

May 18, 2017 | 2:00-3:30 PM ET | Webinar

REMS: Key Issues and Best Practices

May 23, 2017 | 2:00-3:30 PM ET | Webinar

Introduction to U.S. Drug Law and Regulation

June 14-15, 2017 | Boston, MA
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Advertising and Promotion Conference: For the Drug, Medical Device, and Veterinary Industries

September 26-27, 2017 | Washington, DC

Introduction to U.S. Tobacco Law and Regulation

October 25, 2017 | Washington, DC

Tobacco Regulation and Policy Conference: For the Tobacco Products Industry

October 26-27, 2017 | Washington, DC

All Topics — Resources

How to Comply with Drug CGMPs, 2nd Edition

Softbound | 100 pages

LDTs: The Saga Continues

Update Magazine | March/April 2017

Factors to Consider Before Submitting a De Novo Request

Update Magazine | March/April 2017

21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software

Update Magazine | March/April 2017

Interview: James Valentine Talks to Christine McSherry, Jett Foundation

Update Magazine | March/April 2017

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

April 18, 2017 | Food and Drug Policy Forum

FDA-Required Tobacco Product Inserts & Onserts— and the First Amendment

Food and Drug Law Journal | Volume 72 | Number 1

Commemorating the 40th Anniversary of the 1976 Medical Device Amendments

Food and Drug Law Journal | Volume 72 | Number 1

The “Natural” vs. “Natural Flavors” Conflict in Food Labeling: A Regulatory Viewpoint

Food and Drug Law Journal | Volume 72 | Number 1

An Analysis of “Natural” Food Litigation to Build a Sesame Allergy Consumer Class Action

Food and Drug Law Journal | Volume 72 | Number 1

Killing U.S. Slowly: Curing the Epidemic Rise of Cancer Drug Prices

Food and Drug Law Journal | Volume 72 | Number 1

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

False Claims Act Enforcement

April 4, 2017 | On-Demand Webinar

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

March 16, 2017 | On-Demand Webinar

21st Century Cures Act

December 21, 2016 | On-Demand Webinar

The Yates Memo: A Lawyer’s Professional Responsibility

December 14, 2016 | On-Demand Webinar

Social Media: Innovative Uses and Practical Experiences

November 17, 2016 | On-Demand Webinar

Mandatory GMO Labeling: Preparing for Implementation

August 31, 2016 | On-Demand Webinar

New FDA Nutrition Facts Label: Implications for Industry

June 29, 2016 | On-Demand Webinar

Key Takeaways and Interactions between FSMA’s Final Rules

June 29, 2016 | On-Demand Webinar

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

June 15, 2016 | On-Demand Webinar

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

April 21, 2016 | On-Demand Webinar

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

March 14, 2016 | On-Demand Webinar

Marijuana Regulation in the Food and Drug Realm

February 12, 2016 | On-Demand Webinar

Medical Foods Regulation

February 12, 2016 | On-Demand Webinar