FDA Boot Camp

Basic Training for Products Liability and Patent Lawyers

Thursday, May 29, 2008

About

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports…patent concerns…exclusivity… All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. 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 have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The same can be said of 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 and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies, including the nuances of FDAAA.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — 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
    • OTC Approval
    • INDs
    • 510(k) submissions
    • BLAs
    • PMA process

Contents & Contributors

About

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports…patent concerns…exclusivity… All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. 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 have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The same can be said of 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 and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies, including the nuances of FDAAA.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — 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
    • OTC Approval
    • INDs
    • 510(k) submissions
    • BLAs
    • PMA process

Contents & Contributors

THE BASICS: UNDERSTANDING AND WORKING WITH THE FDA
Jayne P. Bultena, Foley Hoag LLP (Washington, DC)

FDA APPROVAL OF DRUGS AND BIOLOGICALS
Gregory H. Levine, Ropes & Gray LLP (Washington, DC)

UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Robert F. Church, Hogan & Hartson (Los Angeles, CA)

PHARMACEUTICAL TRADEMARKS
Dickerson M. Downing, Crowell & Moring, LLP (New York, NY)

HATCH-WAXMAN PATENT OVERVIEW FOR DRUGS AND BIOLOGICS
Joyce L. Morrison, Xencor, Inc. (Monrovia, CA)
Robin M. Silva, Morgan, Lewis & Bockius LLP (San Francisco, CA)

PROPRIETARY NAMES: AGENCY APPROVAL PROCESS
Gretchen R. Stroud, Cooley Godward Kronish LLP (Palo Alto, CA)

FROM THEORY TO PRACTICE: FEDERAL LEGISLATIVE INITIATIVES
Paul T. Kim, Foley Hoag LLP (Boston, MA and Washington, DC)

FROM THEORY TO PRACTICE: OTHER ENFORCEMENT INITIATIVES
Judith A. Waltz, Foley & Lardner LLP (San Francisco, CA)

FDA REGULATION OF ADVERTISING AND PROMOTION OF DRUGS AND BIOLOGICS
William A. McGrath, Wiley Rein LLP (Washington, DC)

REGULATION AND DISSEMINATION OF OFF-LABEL INFORMATION
Christina Markus, King & Spalding LLP (Washington, DC)

ADVERSE EVENTS MONITORING, PHARMACOVIGILANCE AND RISK MANAGEMENT
Bret Koplow, Patton Boggs LLP (Washington, DC)

NON-PATENT EXCLUSIVITIES: WHAT COUNTS? (AND WHAT DOESN’T?)
Eric Rogers, Genentech (South San Francisco, CA)

BIOEQUIVALENCE: WHAT LAWYERS NEED TO KNOW
John D. Carlin, Fitzpatrick, Cella, Harper & Scinto (New York, NY)

FOLLOW-ON (COMPARABLE OR BIOSIMILAR) BIOLOGICS
Donna M. Praiss, Hunton & Williams LLP (New York, NY)
Jessica R. Wolff, Heller Ehrman LLP (San Diego, CA)

MEDICAL DEVICES: CLASSIFICATION AND THE ESSENTIALS OF THE DEVICE PREMARKET REVIEW PROCESS
Siyeon Lee, Goodwin Procter LLP (Washington, DC)

MEDICAL DEVICE LABELING AND ADVERTISING
Evan Phelps, Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)

RECALL GUIDANCE FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES: WHAT YOU NEED TO KNOW
Frederick A. Stearns, Keller Heckman LLP (Washington, DC)



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