Drugs, Medical Devices, Biologics 2017-12-04T12:30:13+00:00

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

Changing Our Minds: Reforming the FDA Medical Device Reclassification Process

Food and Drug Law Journal | Volume 73 | Number 1

FDCA Statutory Supplement, 2018

Softbound | 660 pages

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

How Can FDA Address the Opioid Addiction Crisis?

Update EXTRA | October 27, 2017

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

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