Drugs, Medical Devices, Biologics — Highlights
How to Comply with Drug CGMPs, 2nd Edition
Softbound | 100 pages
FDCA Statutory Supplement, 2017
Softbound | 600 pages
21st Century Cures Act
December 21, 2016 | On-Demand Webinar
Drugs, Medical Devices, Biologics — Programs
Regulation of Cannabis in FDA-Regulated Products
July 19, 2017 | 2:00-3:30 PM ET | Webinar
Key Regulatory Issues in Biosimilars
August 9, 2017 | 2:00 - 3:30 PM ET | Webinar
Introduction to Advertising and Promotion: For the Drug, Medical Device, and Veterinary Medicine Industries
September 25, 2017 | Washington, DC
Advertising and Promotion Conference: For the Drug, Medical Device, and Veterinary Industries
September 26-27, 2017 | Washington, DC
Introduction to U.S. Biologics and Biosimilars Law and Regulation
October 4-5, 2017 | Washington, DC
Introduction to U.S. Drug Law and Regulation
November 2-3, 2017 | Washington, DC
Introduction to U.S. Device Law and Regulation
November 2-3, 2017 | Washington, DC
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
May 3-4, 2018 | Washington, DC
Drugs, Medical Devices, Biologics — Resources
Introduction to U.S. Drug Law and Regulation
November 2-3, 2017 | Washington, DC
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
LDTs: The Saga Continues
Update Magazine | March/April 2017
Factors to Consider Before Submitting a De Novo Request
Update Magazine | March/April 2017
Intellectual Property for the Food and Drug Law Professional: The Product Development Process
Update Magazine | March/April 2017
21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software
Update Magazine | March/April 2017
Interview: James Valentine Talks to Christine McSherry, Jett Foundation
Update Magazine | March/April 2017
Commemorating the 40th Anniversary of the 1976 Medical Device Amendments
Food and Drug Law Journal | Volume 72 | Number 1
Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes
Food and Drug Law Journal | Volume 72 | Number 1
Killing U.S. Slowly: Curing the Epidemic Rise of Cancer Drug Prices
Food and Drug Law Journal | Volume 72 | Number 1
FDCA Statutory Supplement, 2017
Softbound | 600 pages
What’s Missing from MDUFA IV?
October 31, 2016 | Food and Drug Policy Forum
How Will FDA Regulate Off-Label Communications in the Post-Facteau World?
September 26, 2016 | Food and Drug Policy Forum
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
A Practical Guide to FDA’s Food and Drug Law Regulation, 5th Edition
Softbound | 520 Pages
Bringing Your Medical Device to Market, 3rd Edition
Softbound | 450 Pages
Drugs, Medical Devices, Biologics — On-Demand Webinars
Key Regulatory Issues in Biosimilars
August 9, 2017 | 2:00 - 3:30 PM ET | Webinar
The EU’s New Medical Device and IVD Regulations
June 7, 2017 | On-Demand Webinar
REMS: Key Issues and Best Practices
May 23, 2017 | On-Demand Webinar
Compounding Still in the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later
May 18, 2017 | On-Demand Webinar
False Claims Act Enforcement
April 4, 2017 | On-Demand Webinar
Recent FDA Guidance Documents on Manufacturer Communications about Medical Products
March 16, 2017 | On-Demand Webinar
21st Century Cures Act
December 21, 2016 | On-Demand Webinar
The Yates Memo: A Lawyer’s Professional Responsibility
December 14, 2016 | On-Demand Webinar
Social Media: Innovative Uses and Practical Experiences
November 17, 2016 | On-Demand Webinar
Open Payments Data and the Sunshine Act: Managing the Risk of Transparency
March 14, 2016 | On-Demand Webinar
Marijuana Regulation in the Food and Drug Realm
February 12, 2016 | On-Demand Webinar
Medical Foods Regulation
February 12, 2016 | On-Demand Webinar