FDA Boot Camp

Basic Training for Products Liability and Patent Lawyers

Monday, March 31, 2008

About

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And 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.

However, 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.

This publication from ACI’s FDA 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 FDAAA.

Contents & Contributors

About

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And 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.

However, 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.

This publication from ACI’s FDA 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 FDAAA.

Contents & Contributors

THE FOOD AND DRUG ADMINISTRATION — AUTHORITY, ORGANIZATION AND OPERATION
Robert B. Nicholas, McDermott Will & Emery LLP (Washington, DC)

THE NATURE OF THE APPROVAL PROCESS: DRUGS & BIOLOGICS
Erika Lietzan, Covington & Burling LLP (Washington, DC)

UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Scott M. Lassman, WilmerHale (Washington, DC)

PATENT AND IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN, TRADE DRESS, AND MORE
Carmen Shepard, Buc & Beardsley (Washington, DC)
William D. Hare, Concentrx Biosciences, Inc. (Princeton, NJ)

TRADEMARK CLEARANCE AND FDA ISSUES
Patrick J. Concannon, Edwards Angell Palmer & Dodge LLP (Boston, MA)

PRESCRIPTION DRUG (INCLUDING BIOLOGICAL PRODUCT) LABELING
Lauren R. Silvis, Sidley Austin LLP (Washington, DC)

CGMP ENVIRONMENT & IMPACT
I. Scott Bass, Sidley Austin LLP (Washington, DC)

NON – PATENT EXCLUSIVITIES
Shashank Upadhye, Apotex, Inc. (Toronto, ON)

BIOEQUIVALENCE: WHAT PATENT LAWYERS NEED TO KNOW
Chad A. Landmon, Axinn, Veltrop & Harkrider LLP (Hartford, CT)

FOLLOW-ON (COMPARABLE OR BIOSIMILAR) BIOLOGICS
Donald O. Beers, Arnold & Porter LLP (Washington, DC)

POST APPROVAL MARKETING GUIDANCE
James W. Weller, Nixon Peabody LLP (New York, NY)

DIRECT-TO-CONSUMER ADVERTISING
Daniel R. Dwyer, Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

REGULATION AND DISSEMINATION OF OFF-LABEL INFORMATION
Alan G. Minsk, Arnall Golden Gregory LLP (Atlanta, GA)

ADVERSE EVENTS MONITORING (AND OTHER PHARMACOVIGILANCE)
William W. Vodra, Arnold & Porter LLP (Washington, DC)

MEDICAL DEVICES: CLASSIFICATION AND THE ESSENTIALS OF THE DEVICE PREMARKET REVIEW PROCESS
Robert Joel Slomoff, Fulbright & Jaworski LLP (Washington, DC)

POST-MARKET OBLIGATIONS MEDICAL DEVICES
Ralph F. Hall, Baker & Daniels LLP
University of Minnesota Law School (Indianapolis, IN)

INTRODUCTION TO FDA REGULATION OF MEDICAL DEVICE LABELING AND ADVERTISING
Laurie A. Clarke, King & Spalding LLP (Washington, DC)

RECALL GUIDANCE FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES: WHAT YOU NEED TO KNOW
Neil O’Flaherty, Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0