Drugs, Medical Devices, Biologics — Programs
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
May 7-8, 2020 | Washington, DC
Register by February 27, 2020 and SAVE
Enforcement, Litigation, and Compliance Conference
December 11-12, 2019 | Washington, DC
Register by October 10 and SAVE
Introduction to Medical Device Law and Regulation
Two Days in November 2019 | Washington, DC
Introduction to Drug Law and Regulation
Two Days in November 2019 | Washington, DC
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
Introduction to Biologics and Biosimilars Law and Regulation
Two Days in October 2019 | Washington, DC
Introduction to Drug, Biologics, and Biosimilars Law and Regulation
July 23-24, 2019 | Boston, MA
Register by June 20 and SAVE
Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues
July 18, 2019 | 2-3:30 PM EDT | Live Webinar
2019 Law Over Lunch
June 25, 2019 | 12:00-1:30 PM EDT | Washington, DC
Medical Devices: FDA Regulation in the Era of Technology and Innovation
June 6, 2019 | South San Francisco, CA
Precision Medicine: The Evolution of Healthcare
June 5, 2019 | 4:30-7:00 PM PDT | South San Francisco, CA
Fundamentals of Digital Health
June 5, 2019 | South San Francisco, CA
Drugs, Medical Devices, Biologics — Resources
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
The Phenomenon of Financial Toxicity: Healthcare’s Insatiable Disease
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
“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
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
The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Healthspan Promoting Interventions
Food and Drug Law Journal | Volume 74 | Number 1
Toward a Global Solution on Vaccine Liability and Compensation
Food and Drug Law Journal | Volume 74 | Number 1
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
Medical Devices: FDA Regulation in the Era of Technology and Innovation
June 6, 2019 | South San Francisco, CA
Precision Medicine: The Evolution of Healthcare
June 5, 2019 | 4:30-7:00 PM PDT | South San Francisco, CA
Fundamentals of Digital Health
June 5, 2019 | South San Francisco, CA
Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges
Recorded May 14, 2019 | On-Demand Webinar
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
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