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

Drugs, Medical Devices, Biologics — Programs

Enforcement, Litigation, and Compliance Conference

Two Days in December 2018 | Washington, DC

Introduction to US Drug Law and Regulation

Two Days in November 2018 | Washington, DC

Introduction to US Medical Device Law and Regulation

Two Days in November 2018 | Washington, DC

Introduction to US Biologics and Biosimilars Law and Regulation

Two Days in September 2018 | Washington, DC

FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law

May 3-4, 2018 | Washington, DC
Register by February 8 and SAVE

Introduction to US Medical Device Law and Regulation

April 12 - 13, 2018 | Washington, DC
Register by March 8 and SAVE

Introduction to US Drug Law and Regulation

April 12 - 13, 2018 | Washington, DC
Register by March 8 and SAVE

Introduction to US Biologics and Biosimilars Law and Regulation

March 20-21, 2018 | Washington, DC
Register by February 22 and SAVE

Drugs, Medical Devices, Biologics — Resources

FDCA Statutory Supplement, 2018 (Shipping January 30, 2018)

Softbound | 600 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

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