Drugs, Medical Devices, Biologics — Highlights

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

May 4-5, 2017 | Washington, DC
Register By March 31 and SAVE!

FDCA Statutory Supplement, 2017

Softbound | 600 pages

21st Century Cures Act

December 21, 2016 | On-Demand Webinar

Continuing the Discourse: FDA’s Public Hearing on Off-Label Communications

November 17, 2016 | Update EXTRA

Drugs, Medical Devices, Biologics — Programs

Introduction to U.S. Biologics and Biosimilars Law and Regulation

March 15-16, 2017 | Washington, DC

Introduction to U.S. Drug Law and Regulation

April 26-27, 2017 | Washington, DC
Register By March 23 and SAVE!

Introduction to U.S. Medical Device Law and Regulation

April 26-27, 2017 | Washington, DC
Register By March 23 and SAVE!

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

May 4-5, 2017 | Washington, DC
Register By March 31 and SAVE!

Introduction to U.S. Drug Law and Regulation

June 14-15, 2017 | Boston, MA
Register By May 11 and SAVE!

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

September 26-27, 2017 | Washington, DC

Drugs, Medical Devices, Biologics — Resources

FDCA Statutory Supplement, 2017

Softbound | 600 pages

Early Developments in the Regulation of Biologics

Food and Drug Law Journal | Volume 71 | Number 4

FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology

Food and Drug Law Journal | Volume 71 | Number 4

Knowledge Sharing as a Social Dilemma in Pharmaceutical Innovation

Food and Drug Law Journal | Volume 71 | Number 4

FDCA Conviction without Evidence of Knowledge or Intent?

Update Magazine | November/December 2016

New Antitrust Risks from Introducing New Drugs

Update Magazine | November/December 2016

Interview Amy Rick Talks to Stephen Ubl, PhRMA

Update Magazine | November/December 2016

EU Agrees on New Medical Device and IVD Regulation

Update Magazine | November/December 2016

Continuing the Discourse: FDA’s Public Hearing on Off-Label Communications

November 17, 2016 | Update EXTRA

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

Truth, Falsity, and Fraud: Off-Label Drug Settlements and the Future of the Civil False Claims Act

Food and Drug Law Journal | Volume 71 | Number 3

The Law of 180-Day Exclusivity

Food and Drug Law Journal | Volume 71 | Number 3

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

Drugs, Medical Devices, Biologics — On-Demand Webinars

Introduction to U.S. Biologics and Biosimilars Law and Regulation

March 15-16, 2017 | Washington, DC

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

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