FDA Boot Camp

Basic Training for Products Liability and Patent

Tuesday, May 15, 2007

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. 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.

Boost your FDA regulatory IQ. Learn about the FDA approval process and the ins and outs of post-approval challenges.

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.

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:
  • 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 biologics approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring and signal detection
  • Recalls, product withdrawals, and FDA oversight authority

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. 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.

Boost your FDA regulatory IQ. Learn about the FDA approval process and the ins and outs of post-approval challenges.

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.

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:
  • 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 biologics approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring and signal detection
  • Recalls, product withdrawals, and FDA oversight authority

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 King Lietzan, Covington & Burling LLP (Washington, DC)

Understanding the Clinical Trial Process for Drugs and Biologics
Wayne Matelski, Arent Fox PLLC (Washington, DC)

Interaction of FDA Approvals And Patents
Donald O. Beers, Arnold & Porter LLP (Washington, DC)

Hatch-Waxman Patent Overview for Drugs and Biologics
Joyce L. Morrison, Xencor, Inc (Monrovia, CA)
Robin M. Silva, Dorsey & Whitney LLP (San Francisco, CA)

Proprietary Names: Agency Approval Process
Gretchen Stroud, Cooley Godward LLP (Palo Alto, CA)

Drugs and Biologics Labeling
Coleen Klasmeier, Sidley Austin LLP (Washington, DC)

Non-Patent Exclusivities: What Counts? (And What Doesn’t?)
Eric Rogers, Genentech (South San Francisco, CA)

FDA/FTC Regulation of Drug Advertising and Promotion: Advertising and Promotion
Marc H. Bozeman, Hogan & Hartson LLP (Los Angeles, CA)

Direct to Consumer/Patient Promotion
Peter O. Safir, Covington & Burling LLP (Washington, DC)

Follow-On Biologics: Issues and Prospects
Elaine Tseng, King and Spalding LLP (Washington, DC)

Regulation and Dissemination of Off-Label Information
Richard A. Shupack, Pharmaceutical and Biotechnology Regulatory Attorney (San Francisco, CA)

Adverse Events Monitoring
William W. Vodra, Arnold & Porter LLP (Washington, DC)

Classification of Medical Devices and the Essentials of the Device Premarket Review Process
Pamela J. Furman, King & Spalding LLP (Washington, DC)

FDA’s Postmarket Regula
tion of Medical Devices: Requirements, Common Pitfalls, And Recent Development
Pamela J. Furman, King & Spalding LLP (Washington, DC)
Laurie A. Clarke, King & Spalding LLP (Washington, DC)

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 and Weeda, P.C. (Washington, DC)



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