Teleconference Information
Unlocking the Secrets of FDA's Orange Book:
An Introduction to Therapeutic Equivalence, Drug Patents & Exclusivities, and More
A Teleconference Presented by Mr. David Rosen;
Foley & Lardner LLP
Sponsored by FOI Services, Inc. and REEDFAX
Tuesday, August 28, 2007; 1:00 - 2:30 pm EDT (GMT -4)
The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was introduced in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the federal Food, Drug & Cosmetic Act. The Orange Book lists all drug products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products. In 1984, with the passage of the Drug Price Competition Act and Patent Term Restoration Act, the FDA's Orange Book took on additional significance -- it was designated as the repository and official source for identifying affected patents and periods of marketing exclusivity associated with reference products.
All members of the pharmaceutical industry and the organizations supporting them must have a working understanding of the FDA's Orange Book to insure successful navigation of the rigorous FDA approval process, comply with appropriate patent restrictions and marketing exclusivities, anticipate the competitive pressures of upcoming generic products and prepare for the rigors of the legal process inevitably associated with drug approval.
On Tuesday, August 28, at 1:00 pm EDT, join FOI Services, ReedFax, and Mr. David Rosen for a 90-minute teleconference designed to: (a) explain the history of the FDA's Orange Book; (b) review how it is organized and maintained; (c) provide an understanding of the meaning of therapeutic equivalence codes; (d) review how and why patents may be affected and codes associated with those patents; and (e) provide an understanding of the provisions of market exclusivity codes associated with products .
This popular teleconference, first offered in February 2007, was extremely well received -- attendees noted it was a valuable opportunity to gain a thorough understanding and appreciation of the Orange Book. Make sure you can comfortably and confidently use the wealth of information the Orange Book provides -- register today!
What will be covered:
- Why and when FDA's Orange Book was developed
- How to find product information
- What patent information can be listed
- Controversies about listing and delisting patents
- How and when the Orange Book is updated and how to correct inaccurate information
- The meaning of Therapeutic Equivalence codes and how they are used by state Boards of Pharmacy and Pharmacists
- The various types of exclusivity and their impact on product approval
- Practical tips for using this information in product development and approval
What You'll Learn:
- How to easily navigate and understand the contents of the FDA's Orange Book
- Why the book is Orange
- How to mine the Orange Book for the information you need in developing and protecting products
- What to do if you suspect Orange Book information is inaccurate
- Why and when patent information is included in product records
- How to interpret marketing exclusivity information
- Why it is important to monitor the Orange Book regularly
- How the drug approval process and the Orange Book interrelate
What You'll Get:
- A thorough working knowledge of the FDA's Orange Book
- An understanding of why FDA is involved with patent terms
- Practical insight into the importance of the information in the Orange Book
- An understanding and appreciation of the relationship of the NDA and ANDA drug approval process and the Orange Book
- Links to the Orange Book and to corresponding information about approved biologic products and veterinary drugs
- Links to responsible FDA staff
- Regulatory and legal perspectives
- An experienced and engaging instructor who was a principal author of the FDA's Orange Book and a respected member of the FDA Bar
About Your Presenter:
David Rosen is a partner and co-chair of Foley & Lardner's Life Sciences Industry Team. He is also a member of the firm's Public Affairs Practice and the Health Care Industry and Food Industry Teams. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. Mr. Rosen was formerly a partner with the law firm of DLA Piper Rudnick Gray Cary. Prior to that he was a partner at McDermott, Will & Emery. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process and related compliance activity. He was particularly involved in generic drug products, and was one of the originators of the FDA's Orange Book.
Who Should Attend:
Anyone responsible for, or affected by, FDA pharmaceutical regulations:
- Management
- Legal staff
- Drug patent researchers
- Regulatory affairs personnel
- Product development professionals
- Business development and competitive intelligence staff
- Library and information specialists
