Drugs, Medical Devices, Biologics — Programs
Advertising and Promotion for Medical Products Conference
October 6-7 | Washington, DC
Register by July 23 and SAVE
Introduction to Advertising and Promotion for Medical Products
October 5 | Washington, DC
Register by July 23 and SAVE
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
To Be Announced | Washington, DC
Register by April 2 and SAVE
Introduction to Drug Law and Regulation
April 15-16 | Virtual Event
DQSA – Updates in Compounding Conference
To Be Announced | Virtual Event
Introduction to Medical Device Law and Regulation
April 7-8 | Virtual Event
Regenerative Medicine: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies
April 2, 2020 | Virtual Event
The Challenges of Communicating Regulatory Status to the Public
Update Magazine | November/December 2019
Brazil: New Regulation of Cannabis-Based Drugs Coming Soon
Update Magazine | November/December 2019
Introduction to Medical Device Law and Regulation
November 13-14, 2019 | Washington, DC
Introduction to Drug, Biologics, and Biosimilars Law and Regulation
July 23-24, 2019 | Boston, MA
6th Annual Eric M. Blumberg Memorial Lecture
6th Annual Eric M. Blumberg Memorial Lecture | December 13, 2018
5th Annual Eric M. Blumberg Memorial Lecture
5th Annual Eric M. Blumberg Memorial Lecture | December 7, 2017
Drugs, Medical Devices, Biologics — Resources
Ready or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared?
Update Magazine | November/December 2019
CBD Enforcement– Who is Keeping Watch?
Update Magazine | November/December 2019
The Challenges of Communicating Regulatory Status to the Public
Update Magazine | November/December 2019
Brazil: New Regulation of Cannabis-Based Drugs Coming Soon
Update Magazine | November/December 2019
PMA Advisory Panels: Do their Votes Matter?
Update Magazine | April/May 2019
Device Cybersecurity: How FDA and Others are Collaborating to Increase Patient Safety
Update Magazine | April/May 2019
Canada 2018 Year in Review: Top 10 Medical Device Regulatory Issues
Update Magazine | April/May 2019
Over-the-Counter Drug Monograph Reform Legislation in the 116th Congress
Update Magazine | April/May 2019
Communicating with FDA When Data Integrity Issues Arise During Clinical Trials
Update Magazine | April/May 2019
Global Regulatory Focus | China: Survival of the Fittest or Cheapest
Update Magazine | April/May 2019
Toward a Global Solution on Vaccine Liability and Compensation
Food and Drug Law Journal | Volume 74 | Number 1
The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Healthspan Promoting Interventions
Food and Drug Law Journal | Volume 74 | Number 1
Blurred Lines: The Collapse of the Research/Clinical Care Divide and the Need for Context-Based Research Categories in the Revised Common Rule
Food and Drug Law Journal | Volume 74 | Number 1
“Left To Our Own Devices, What Did We Get Wrong?” The Medical Device Amendments of 1976 as Seen from the Insider’s View
Food and Drug Law Journal | Volume 74 | Number 1
Left to Their Own Devices: How the Dangers of Power Morcellators Went Undetected by FDA for Two Decades
Food and Drug Law Journal | Volume 74 | Number 1
The Phenomenon of Financial Toxicity: Healthcare’s Insatiable Disease
Food and Drug Law Journal | Volume 74 | Number 1
6th Annual Eric M. Blumberg Memorial Lecture
6th Annual Eric M. Blumberg Memorial Lecture | December 13, 2018
Guidance on Guidance: FDA, DOJ, and Enforcement
Recorded August 21, 2018 | On-Demand Webinar
5th Annual Eric M. Blumberg Memorial Lecture
5th Annual Eric M. Blumberg Memorial Lecture | December 7, 2017
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
Regenerative Medicine: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies
April 2, 2020 | Virtual Event
FDA-Related Congressional Committees: Jurisdiction, Focus, and Roles
Recorded March 4, 2020 | On-Demand Webinar
The Challenges of Communicating Regulatory Status to the Public
Update Magazine | November/December 2019
Brazil: New Regulation of Cannabis-Based Drugs Coming Soon
Update Magazine | November/December 2019
Introduction to Medical Device Law and Regulation
November 13-14, 2019 | Washington, DC
Class Action of FDA-Regulated Products: Recent Updates and Future Forecasts
Recorded August 21, 2019 | On-Demand Webinar
Introduction to the Regulation of Cannabis-Derived Products
Recorded August 1, 2019 | On-Demand Webinar
Introduction to Product Liability Regarding FDA-Regulated Products
Recorded July 23, 2019 | On-Demand Webinar
Introduction to Drug, Biologics, and Biosimilars Law and Regulation
July 23-24, 2019 | Boston, MA
Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues
Recorded July 18, 2019 | On-Demand Webinar
Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges
Recorded May 14, 2019 | On-Demand Webinar
6th Annual Eric M. Blumberg Memorial Lecture
6th Annual Eric M. Blumberg Memorial Lecture | December 13, 2018
New Management Standards for Hazardous Waste Pharmaceuticals and Nicotine
Recorded March 6, 2019 | On-Demand Webinar
Patient Assistance Programs: Recent Enforcement and Best Practices
Recorded February 7, 2019 | 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
5th Annual Eric M. Blumberg Memorial Lecture
5th Annual Eric M. Blumberg Memorial Lecture | December 7, 2017
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