Drugs, Medical Devices, Biologics — Programs
Advertising and Promotion for Medical Products Conference
October 17-18, 2019 | Washington, DC
Introduction to Advertising and Promotion for Medical Products
October 16, 2019 | Washington, DC
Register by February 7 and SAVE
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
May 2-3, 2019 | Washington, DC
Register by February 7 and SAVE
Enforcement, Litigation, and Compliance Conference
For the Drug, Device, Food and Tobacco Industries
December 12-13, 2018 | Washington, DC
Register by October 18 and SAVE
Drug Quality and Security Act Conference
December 4, 2018 | Washington, DC
Register by November 8 and SAVE
Introduction to Medical Device Law and Regulation
November 7-8, 2018 | Washington, DC
Introduction to Drug Law and Regulation
November 7-8, 2018 | Washington, DC
Patient Organizations: An Introduction to Drug Law and Regulation
November 7-8, 2018 I Washington, DC
For non-profit professionals only
Food and Drug Law Journal 2018 Symposium
What Is the Path Forward for Federal Regulation of Cannabis?
November 2, 2018 | Washington, DC
Drugs, Medical Devices, Biologics — Resources
Introduction to Advertising and Promotion for Medical Products
October 16, 2019 | Washington, DC
Register by February 7 and SAVE
Medical Device Crowdfunding and Pre-Approval Promotion: Where Does FDA Draw the Line?
Update Magazine | October/November 2018
Epidiolex Approval Suggests the Way Forward for Marijuana-Derived Products
Update Magazine | October/November 2018
Digital Health – FDA’s Approach Will Continue to Evolve
Update Magazine | October/November 2018
Case Study: Jazz Pharmaceuticals v. Amneal Pharmaceuticals
Update Magazine | October/November 2018
Student Corner: Right to Try Act: Is it the Answer for Terminally Ill Patients?
Update Magazine | October/November 2018
Global Focus: Clinical Trials in India
Update Magazine | October/November 2018
When Markets Fail: Patents and Infectious Disease Products
Food and Drug Law Journal | Volume 73 | Number 3
Buying and Selling Prioritized Regulatory Review: The Market for Priority Review Vouchers as Quasi-Intellectual Property
Food and Drug Law Journal | Volume 73 | Number 3
Obsolete to Useful to Obsolete Once Again: A History of Section 507 of the Food, Drug, and Cosmetic Act
Food and Drug Law Journal | Volume 73 | Number 3
Guidance on Guidance: FDA, DOJ, and Enforcement
Recorded August 21, 2018 | On-Demand Webinar
Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape
Update Magazine | August/September 2018
FDA’s Historical Use of “Real World Evidence”
Update Magazine | August/September 2018
For FDA, Addressing Drug Pricing Is a Matter of Doing Its Job Better
Update Magazine | August/September 2018
The DEA Quota System
Update Magazine | August/September 2018
Public Law 115-92: A New Era of Collaboration between DoD and FDA
Update Magazine | August/September 2018
Canada’s Green Rush – Getting Ready for The Legalization of Adult-Use Cannabis
Update Magazine | August/September 2018
FDA in the New Administration: Policy and Enforcement Priorities for the Coming Year
Update Magazine | June/July 2018
Commemorating the 80th anniversary of the Passage of the 1938 Food, Drug, and Cosmetic Act
Update Magazine | June/July 2018
Consultants as Part of the Legal Team
Update Magazine | June/July 2018
FDCA Statutory Supplement, 2018
Softbound | 660 pages
How Can FDA Address the Opioid Addiction Crisis?
Update EXTRA | October 27, 2017
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 to Comply with Drug CGMPs, 2nd Edition
Softbound | 100 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
Drugs, Medical Devices, Biologics — On-Demand Webinars
Introduction to Advertising and Promotion for Medical Products
October 16, 2019 | Washington, DC
Register by February 7 and SAVE
From Approval to Coverage – FDA and CMS Jurisdictional Lines
Recorded September 27, 2018 | On-Demand Webinar
Guidance on Guidance: FDA, DOJ, and Enforcement
Recorded August 21, 2018 | On-Demand Webinar
Drug Pricing for the Food and Drug Community
Recorded July 17, 2018 | On-Demand Webinar
DEA Law for the Food and Drug Community
Recorded May 30, 2018 | On-Demand Webinar
Real World Evidence: Data Requirements, Utilization, and Presentation
Recorded December 1, 2017 | On-Demand Webinar
Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for Industry
Recorded November 29, 2017 | On-Demand Webinar
Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights
Recorded November 17, 2017 | On-Demand Webinar
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