Drugs, Medical Devices, Biologics — Programs

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

September 26-27, 2017 | Washington, DC

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

October 4-5, 2017 | Washington, DC

Food and Drug Law Journal 2017 Symposium

October 20, 2017 | Washington, DC

Introduction to U.S. Drug Law and Regulation

November 2-3, 2017 | Washington, DC

Introduction to U.S. Device Law and Regulation

November 2-3, 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

Drugs, Medical Devices, Biologics — 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

Case Note: Sandoz v. Amgen

Update Magazine | July/August 2017

FDA Sharpens its Focus on Regenerative Medicine Regulation

Update Magazine | July/August 2017

Remarks by Acting FDA Commissioner Stephen M. Ostroff, MD

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

The Compounding Conundrum

Food and Drug Law Journal | Volume 72 | Number 3

How to Comply with Drug CGMPs, 2nd Edition

Softbound | 100 pages

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

Bringing Your Medical Device to Market, 3rd Edition

Softbound | 450 Pages

Drugs, Medical Devices, Biologics — 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

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