Drugs, Medical Devices, Biologics — Programs
Advertising and Promotion for Medical Products Conference
October 17-18, 2019 | Washington, DC
Register by August 1 and SAVE
Introduction to Advertising and Promotion for Medical Products
October 16, 2019 | Washington, DC
Register by August 1 and SAVE
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
May 2-3, 2019 | Washington, DC
Register by March 21 and SAVE
Introduction to Medical Device Law and Regulation
April 11-12, 2019 | Washington, DC
Register by March 14 and SAVE
Introduction to Drug Law and Regulation
April 11-12, 2019 | Washington, DC
Register by March 14 and SAVE
Introduction to Biologics and Biosimilars Law and Regulation
April 2-3 2019 | Washington, DC
Register by March 7 and SAVE
New Management Standards for Hazardous Waste Pharmaceuticals and Nicotine
March 6, 2019 | 2:00-3:30 pm | Live Webinar
Drugs, Medical Devices, Biologics — Resources
Patient Assistance Programs: Recent Enforcement and Best Practices
Recorded February 7, 2019 | On-Demand Webinar
Opioid Legislation: The Path Forward for FDA and DEA Webinar
Recorded December 18, 2018 | On-Demand Webinar
No Longer Business as Usual: FDA Exceptionalism, Commercial Speech, and the First Amendment
Food and Drug Law Journal | Volume 73 | Number 4
The Evolving Regulatory Landscape for Clinical Trials in India
Food and Drug Law Journal | Volume 73 | Number 4
The Responsible Corporate Officer Doctrine: Protections are Needed Despite DOJ’s Cautious Approach
Update Magazine | December 2018/January 2019
Un-“Stacking” Class Actions
Update Magazine | December 2018/January 2019
A Storm Is Brewing: What Happened to the Generic Pharmaceutical Anti-Trust Price Fixing Criminal Investigation?
Update Magazine | December 2018/January 2019
Gene Therapy – FDA Takes Steps Toward Clarifying Scope of Orphan Drug Exclusivity
Update Magazine | December 2018/January 2019
FDA’s New Pilot Program Encouraging Innovation
Update Magazine | December 2018/January 2019
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
FDCA Statutory Supplement, 2018
Softbound | 660 pages
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
Patient Assistance Programs: Recent Enforcement and Best Practices
Recorded February 7, 2019 | On-Demand Webinar
Opioid Legislation: The Path Forward for FDA and DEA Webinar
Recorded December 18, 2018 | On-Demand Webinar
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