Drugs, Medical Devices, Biologics — Programs
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
Introduction to US Medical Device Law and Regulation
November 7-8, 2018 | Washington, DC
Register by October 4 and SAVE
Introduction to US Drug Law and Regulation
November 7-8, 2018 | Washington, DC
Register by October 4 and SAVE
Food and Drug Law Journal 2018 Symposium
November 2, 2018 | Washington, DC
FDA: Past, Present, and Future
October 19, 2018 | Washington, DC
Advertising and Promotion Conference
For the Drug, Medical Device, and Veterinary Industries
October 16-17, 2018 | Washington, DC
Register by July 19 and SAVE
Introduction to Advertising and Promotion
For the Drug, Medical Device, and Veterinary Industries
October 15, 2018 | Washington, DC
Register by July 19 and SAVE
Introduction to US Biologics and Biosimilars Law and Regulation
October 3-4, 2018 | Washington, DC
Register by September 6 and SAVE
Introduction to US Medical Device Law and Regulation
July 26-27, 2018 | South San Francisco, CA
Register by June 21 and SAVE
FDA’s Digital Health Innovation Action Plan – Key Updates
Panel Discussion and Networking Reception
July 25, 2018 | South San Francisco, CA
Introduction to US Drug Law and Regulation
July 24-25, 2018 | South San Francisco, CA
Register by June 21 and SAVE
Center for Devices and Radiological Health: What’s Ahead for 2018 and Beyond
Panel Discussion and Networking Reception
July 17, 2018 | Boston, MA
Guidance on Guidance: FDA, DOJ, and Enforcement
July 12, 2018 | 2:00 - 3:00 pm ET | Live Webinar
FDA’s Tools to Respond to Public Health Emergencies
Update Magazine | March/April 2018
FDA Data Integrity Enforcement Trends and Practical Mitigation Measures
Update Magazine | March/April 2018
Protecting Trade Secrets in the Medical Product Approval Process
Update Magazine | March/April 2018
Careers in Food and Drug Law
March 28, 2018 | Philadelphia, PA
Drugs, Medical Devices, Biologics — Resources
Organic Chemistry for the Food and Drug Community
Recorded June 21, 2018 | On-Demand Webinar
Off-Label Communications: The Prodigal Returns
Off-Label Communications: The Prodigal Returns
Jeffery Chasnow and Geoffrey Levitt
INTRODUCTION
Recent changes in law and policies relating to “off-label” product communications by manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son.1 In the parable, […]
What’s New at FDA for Medical Products and Foods?
Update Magazine | March/April 2018
FDA’s Tools to Respond to Public Health Emergencies
Update Magazine | March/April 2018
FDA Data Integrity Enforcement Trends and Practical Mitigation Measures
Update Magazine | March/April 2018
Protecting Trade Secrets in the Medical Product Approval Process
Update Magazine | March/April 2018
China: Breaking Down the “Great Wall”?
Update Magazine | March/April 2018
Top 10 Updates on Canadian Market Access, Exclusivity, and Pricing Issues
Update Magazine | March/April 2018
Data Integrity: FDA Enforcement and Risk-Reduction Considerations
Recorded March 13, 2018 | On-Demand Webinar
Navigating an FTC Drug Pricing Investigation
Update Magazine | January/February 2018
Eye on Enforcement
Update Magazine | January/February 2018
5th Annual Blumberg Lecture
Update Magazine | January/February 2018
Genomic Malpractice: An Emerging Tide or Gentle Ripple?
Food and Drug Law Journal | Volume 72 | Number 4
Step Therapy: Legal, Ethical, and Policy Implications of a Cost-Cutting Measure
Food and Drug Law Journal | Volume 73 | Number 1
Recommendations for Regulating Software-Based Medical Treatments: Learning from Therapies for Psychiatric Conditions
Food and Drug Law Journal | Volume 73 | Number 1
Good Public Health Policy, Better Public Health Law: Blood Donation, Individual Risk Assessments, & Lifting the Deferral for Men Who Have Sex with Men
Food and Drug Law Journal | Volume 73 | Number 1
Is the Incorporation of the United States Pharmacopeia into the Food, Drug, and Cosmetic Act an Unconstitutional Delegation of Legislative Power?
Food and Drug Law Journal | Volume 73 | Number 1
Changing Our Minds: Reforming the FDA Medical Device Reclassification Process
Food and Drug Law Journal | Volume 73 | Number 1
New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures
Recorded February 9, 2018 | On-Demand Webinar
FDCA Statutory Supplement, 2018
Softbound | 660 pages
DEA Preregistration and Cyclic Inspections: What Applicants and Registrants Must Know in the Prescription Opioid Epidemic Age
Update Magazine | November/December 2017
Capturing Postmarket Benefits in Device Compliance and Enforcement
Update Magazine | November/December 2017
Those Involved in Compound Pharmaceuticals Beware: Law Enforcement Is Focused on You
Update Magazine | November/December 2017
Kid Tested, FDA Approved: Examining Pediatric Drug Testing
Food and Drug Law Journal | Volume 72 | Number 4
When the Alpha is the Omega: P-Values, “Substantial Evidence,” and the 0.05 Standard at FDA
Food and Drug Law Journal | Volume 72 | Number 4
The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls
Update Magazine | September/October 2017
Brand Name Preemption: The New Frontier In Pharmaceutical Product Liability Litigation
Food and Drug Law Journal | Volume 72 | Number 4
The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI
Update Magazine | November/December 2017
Getting by with a Little Help from Their Friends: FDA Using External Experts to Enhance Biomarker Qualification and Enable Precision
Food and Drug Law Journal | Volume 72 | Number 4
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 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
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
Organic Chemistry for the Food and Drug Community
Recorded June 21, 2018 | On-Demand Webinar
DEA Law for the Food and Drug Community
Recorded May 30, 2018 | On-Demand Webinar
FDA’s Tools to Respond to Public Health Emergencies
Update Magazine | March/April 2018
FDA Data Integrity Enforcement Trends and Practical Mitigation Measures
Update Magazine | March/April 2018
Protecting Trade Secrets in the Medical Product Approval Process
Update Magazine | March/April 2018
Careers in Food and Drug Law
March 28, 2018 | Philadelphia, PA
Data Integrity: FDA Enforcement and Risk-Reduction Considerations
Recorded March 13, 2018 | On-Demand Webinar
New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures
Recorded February 9, 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