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.
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.
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.
In the is publication 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
- 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
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.
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.
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.
In the is publication 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
- 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 FOOD AND DRUG ADMINISTRATION: AUTHORITY, ORGANIZATION
AND OPERATION A PRACTICAL GUIDE
Robert B. Nicholas, McDermott Will & Emery LLP (Washington, DC)
THE NATURE OF THE APPROVAL PROCESS
Erika Lietzan, Covington & Burling LLP (Washington, DC)
UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS
AND BIOLOGICS
Scott M. Lassman, WilmerHale (Washington, DC)
BASIC TRAINING FOR PRODUCTS LIABILITY AND PATENT LAWYERS
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)
DRUGS AND BIOLOGICAL PRODUCTS: LABELING
Sheldon T. Bradshaw, Hunton & Williams LLP (Washington, DC)
BASIC TRAINING FOR PRODUCTS LIABILITY AND PATENT LAWYERS
Robert A. Dormer, Hyman, Phelps & McNamara, P.C. (Washington, DC)
NON-PATENT EXCLUSIVITY
Aaron F. Barkoff, Ph.D., McDonnell Boehnen Hulbert & Berghoff LLP
(Chicago, IL)
BIOEQUIVALENCE: WHAT PATENT LAWYERS NEED TO KNOW
Chad A. Landmon, Axinn, Veltrop & Harkrider LLP (Hartford, CT)
FOLLOW-ON BIOLOGICS: THE EVOLUTION OF AN APPROVAL PATHWAY
Donald R. Ware, Foley Hoag LLP (Boston, MA)
ADVERTISING AND PROMOTION
Joseph J. Leghorn, Nixon Peabody LLP (Boston, MA)
James W. Weller, Esq., Nixon Peabody LLP (Boston, MA)
DIRECT-TO-CONSUMER ADVERTISING
Daniel R. Dwyer, Kleinfeld, Kaplan & Becker, LLP (Washington, DC)
(SOME) LEGAL AND REGULATORY ISSUES TO CONSIDER WITH
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
Grail Walsh Sipes, Covington & Burling LLP (Washington, DC)
POST-MARKET OBLIGATIONS MEDICAL DEVICES
Ralph F. Hall, Baker & Daniels LLP (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 F. O’Flaherty, Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)
Publication Details