Drugs, Medical Devices, Biologics — Programs
Introduction to Advertising and Promotion: For the Drug, Medical Device, and Veterinary Medicine Industries
September 25, 2017 | Washington, DC
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
Facing a Multiproduct Recall: Best Practices to Ensure Compliance with FDA Regulations and Pitfalls to Avoid
October 10, 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
Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries
December 6-7, 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
Prescription Drug Advertising and Promotion Regulations and Enforcement in Select Global Markets
Update Magazine | July/August 2017
“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
The Butterfly Effect: Reuse of a Needle Guide Triggers “Fundamental Threat to Federal-State Balance”
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
Effective Review and Approval of Digital Promotional Tactics, 2nd Edition
Softbound | 236 pages
A Practical Guide to FDA’s Food and Drug Law Regulation, 6th Edition
Softbound | 550 Pages
How Can Global Markets Establish and Implement Efficient, Flexible, and Effective Global Pharmaceutical Serialization and Traceability Systems?
May 2, 2017 | Food and Drug Policy Forum
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