FDA Boot Camp

Basic Training for Products Liability and Patent Lawyers

Monday, March 27, 2006

About

Be a Better Life Sciences Products Litigator or Patent Attorney...
Learn about the FDA approval process and the ins and outs of post-approval challenges


The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity. These are all 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.

However, many products liability lawyers and patent counsel - 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. Today, this lack of knowledge has become a great handicap for these lawyers as litigation in products liability and patents concerning these products often hinges on what happened during the pre-approval, approval or post-approval periods. Every phase of litigation - from discovery to trial - concerning FDA-regulated products is in some way affected by occurrences during these critical phases.

ACI's FDA Boot Camp publication has been developed to give products or patent litigators, as well as patent prosecutors, a strong working knowledge of core FDA regulatory competencies.

Get critical insights on:
  • The organization, jurisdiction, functions, and operations of the FDA
  • The new role of CMS in the drug approval process
  • 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

Be a Better Life Sciences Products Litigator or Patent Attorney...
Learn about the FDA approval process and the ins and outs of post-approval challenges


The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity. These are all 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.

However, many products liability lawyers and patent counsel - 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. Today, this lack of knowledge has become a great handicap for these lawyers as litigation in products liability and patents concerning these products often hinges on what happened during the pre-approval, approval or post-approval periods. Every phase of litigation - from discovery to trial - concerning FDA-regulated products is in some way affected by occurrences during these critical phases.

ACI's FDA Boot Camp publication has been developed to give products or patent litigators, as well as patent prosecutors, a strong working knowledge of core FDA regulatory competencies.

Get critical insights on:
  • The organization, jurisdiction, functions, and operations of the FDA
  • The new role of CMS in the drug approval process
  • 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

NEW CONSIDERATIONS IN DRUG AND BIOLOGICALS PRODUCT DEVELOPMENT FOR THE NEW MILLENNIUM: CMS, PBM, P&T COMMITTEES AND MORE
Edward John Allera, Buchanan Ingersoll

FDA BOOT CAMP: THE APPROVAL PROCESS
Erika King Lietzan, Covington & Burling

UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Marsha Wertzberger, Arent Fox

PATENT AND IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN, TRADE DRESS, AND MORE
William D. Hare, Ranbaxy Pharmaceuticals Inc.

PTO AND FDA REVIEW OF PHARMACEUTICAL TRADEMARKS: A TALE OF TWO AGENCIES
Dickerson M. Downing, Morgan & Finnegan

DRUGS AND BIOLOGICS LABELING
Coleen Klasmeier, Sidley Austin Brown & Wood LLP

CGMPS ENVIRONMENT & IMPACT
I. Scott Bass, Sidley Austin Brown & Wood LLP
Steve Payne, Sidley Austin Brown & Wood LLP

NEW DRUG APPLICATIONS UNDER SECTION 505(b)(2) OF THE FEDERAL FOOD DRUG & COSMETIC ACT: THE HATCH-WAXMAN ACT IN MICROCOSM
Carlos T. Angulo, Zuckerman Spaeder LLP

"FDA EXCLUSIVITIES":A (LIMITED) COMPLEMENT TO THE PATENT SYSTEM
Carlos T. Angulo, Zuckerman Spaeder LLP

FDA/FTC REGULATION OF DRU ADVERTISING AND PROMOTION
Phillip Katz, Hogan & Hartson

BIOEQUIVALENCE RULINGS
John C. Vassil, Morgan & Finnegan

FDA BOOT CAMP: FOLLOW-ON BIOLOGICS
Donald O. Beers, Arnold & Porter

SPECIAL CONCERNS FOR DTC ADVERTISING
Tracy L. Acker, Reed Smith

REGULATION AND DISSEMINATION OF OFF-LABEL INFORMATION
Jeffrey N. Gibbs, Hyman, Phelps & McNamara, P.C.

ADVERSE EVENTS MONITORING
William Vodra, Arnold & Porter LLP

CLASSIFICATION OF MEDICAL DEVICES AND THE ESSENTIALS OF THE DEVICE APPROVAL PROCESS
Pamela J. Furman, Olsson, Frank and Weeda, P.C.

FDA BOOT CAMP: 510(k) PREMARKET NOTIFICATIONS
Laurie A. Clarke, King & Spalding LLP

THE MEDICAL DEVICE PMA PROCESS
Gerard J. Prud'homme, Hogan & Hartson

MARKETING AND PROMOTIONAL CONSIDERATIONS FOR DEVICES
Jennifer A. Davidson, Kleinfeld, Kaplan and Becker, LLP

RECALL GUIDANCE FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES - WHAT YOU NEED TO KNOW
Neil O'Flaherty, Olsson, Frank and Weeda, P.C.



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0