About
This Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of the one of the most comprehensive revisions of FDA law in decades, the FDA Amendments Act of 2007 (FDAAA).
Many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.
However, recent court cases and high-profile trials concerning FDA-regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on securities experts and business executives in the life sciences arena. Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.
Designed specifically to provide you with a clear understanding of this complicated area, a distinguished faculty of top FDA regulatory experts — a “ Who's Who of the FDA Bar ” — will share their knowledge and give you critical insights on:
- The organization, jurisdiction, functions, and operations of the FDA
- The essentials of the approval process for drugs, biologics, and devices, including:
- NDAs
- INDs
- BLAs
- OTC approval
- 510 K submissions
- PMA process
- Clinical trials for drugs and biologics and the clearance process for devices
- The classification of devices and the concept of “risk-based” classification
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Labeling in the drug and biological products approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring
- Recalls, product withdrawals, and FDA oversight authority
About
This Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of the one of the most comprehensive revisions of FDA law in decades, the FDA Amendments Act of 2007 (FDAAA).
Many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.
However, recent court cases and high-profile trials concerning FDA-regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on securities experts and business executives in the life sciences arena. Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.
Designed specifically to provide you with a clear understanding of this complicated area, a distinguished faculty of top FDA regulatory experts — a “ Who's Who of the FDA Bar ” — will share their knowledge and give you critical insights on:
- The organization, jurisdiction, functions, and operations of the FDA
- The essentials of the approval process for drugs, biologics, and devices, including:
- NDAs
- INDs
- BLAs
- OTC approval
- 510 K submissions
- PMA process
- Clinical trials for drugs and biologics and the clearance process for devices
- The classification of devices and the concept of “risk-based” classification
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Labeling in the drug and biological products approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring
- Recalls, product withdrawals, and FDA oversight authority
Contents & Contributors
The Basics: Understanding and Working with the FDA and the Obama Administration – Jurisdiction, Functions, Organizations, & Operations
Robert B. Nicholas, Partner, McDermott Will & Emery LLP (Washington, D.C.)
The Nature of the Approval Process
Erika Lietzan, Partner, Covington & Burling LLP (Washington, D.C.)
Essential Requirements of the Clinical Trials Processes
Scott M. Lassman, Partner, WilmerHale (Washington, D.C.)
Patent & IP Spotlight: Hatch-Waxman, the Patenting Process, and More
Bruce M. Wexler, Partner, Paul Hastings Janofsky & Walker LLP (New York, NY)
Drugs, Biological, and Medical Device Products: Labeling
Sheldon T. Bradshaw, Partner, Hunton & Williams LLP (Washington, D.C.)
Current Good Manufacturing Practices (cGMPs) and Quality System Regulation (QSR)
Robert Dormer, Director, Hyman, Phelps, & McNamara P.C. (Washington, D.C.)
Non-Patent Exclusivity
Aaron F. Barkoff, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP, (Chicago, IL)
Bioequivalence: What Patent Lawyers Need to Know
Chad A. Landmon, Partner, Axinn Veltrop & Harkrider LLP, (Hartford, CT and Washington, D.C.)
Follow-On (Comparable or Biosimilar) Biologics
Donald R. Ware, Partner, Foley Hoag, LLP (Boston, MA)
Advertising and Promotion
Karen Weaver, Partner, Baker Hostetler (Los Angeles, CA)
Regulation and Dissemination of Off-Label Information
Alan G. Minsk, Partner, Arnall Golden Gregory LLP (Atlanta, GA)
Preemption Fundamentals
Mark Herrmann, Partner, Jones Day, (Chicago, IL)
Publication Details