Drugs, Medical Devices, Biologics — Highlights

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

Drugs, Medical Devices, Biologics — Programs

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

September 26-27, 2017 | Washington, DC

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

May 3-4, 2018 | Washington, DC

Drugs, Medical Devices, Biologics — 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

Commemorating the 40th Anniversary of the 1976 Medical Device Amendments

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

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

The EU’s New Medical Device and IVD Regulations

June 7, 2017 | On-Demand Webinar

REMS: Key Issues and Best Practices

May 23, 2017 | On-Demand Webinar

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

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