Virtual | Virtual

Event Title

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book

October 27 - 28, 2020

Scheduled

Date:: October 27 - 28, 2020
Day1:: Tue, Oct 27 8:00 AM - 4:40 PM ET
Day2:: Wed, Oct 28 8:45 AM - 4:05 PM ET

Presentation	Presenter
Orange Book 101: An Overview of FDA's Orange Book	Camille Smith DLRS \| OGDP \| OGD
How to Update Orange Book Information	Kendra Stewart Kun Shen CDR, USPHS DLRS \| OGDP \| OGD \| CDER Eunice Chung-Davies CAPT, USPHS Division of User Fee Management and Budget Formulation (DUFMBF) Office of Management (OM) \| CDER
How to Update Orange Book Information – Panel Discussion	Kendra Stewart, Kun Shen, Eunice Chung-Davies and Elizabeth Friedman Division of Policy Development (DPD) OGDP \| OGD \| CDER
An Overview of FDA's Patent Listing Process	Kun Shen CDR, USPHS DLRS \| OGDP \| OGD \| CDER
Changes to Orange Book Patent Information	Alicia Chen DLRS \| OGDP \| OGD \| CDER
Orange Book Patent Information – Panel Discussion	Kun Shen, Alicia Chen and Janice Weiner Division of Regulatory Policy I (DRPI) Office of Regulatory Policy (ORP) \| CDER
The Patent Information Dispute Process	Alicia Chen DLRS \| OGDP \| OGD \| CDER
Best Practices for 505(b)(2) and ANDA Applicants	Mary Ann Holovac Division of Regulatory Policy (DRP) Office of New Drug Policy (ONDP) Office of New Drugs (OND) Andrew Coogan DLRS \| OGDP \| OGD \| CDER
Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion	Alicia Chen, Mary Ann Holovac, Andrew Coogan, and Jennifer Gerton Office of the Chief Counsel (OCC)
Orange Book Exclusivity: An Introduction and Overview	Truong Quach DLRS\|OGDP\|OGD
Orange Book Exclusivity: Part I - NCE and 3-Year	Nisha Shah Division of Regulatory Policy I (DRPIV) Office of Regulatory Policy (ORP)
Orange Book Exclusivity – Panel Discussion	Truong Quach, Nisha Shah Alicia Chen and Christopher Pruitt DLRS \| OGDP \| OGD \| CDER
Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN	Kristiana Brugger Division of Regulatory Policy IV (DRPIV) Office of Regulatory Policy (ORP) \| CDER Aaron Friedman Office of Orphan Products Development (OOPD) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC) Katherine Schumann Division of Regulatory Policy (DRP) Office of New Drug Policy (ONDP) OND \| CDER
Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities	Jonathan Hughes Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD \| CDER Mindy Ehrenfried DPD \| OGDP \| OGD \| CDER
Orange Book Exclusivity – Panel Discussion	Kristiana Brugger, Aaron Friedman, Katherine Schumann, Jonathan Hughes, Mindy Ehrenfried
Orange Book: An Overview of Therapeutic Equivalence	Elizabeth Friedman DPD \| OGDP \| OGD \| CDER
Referencing Approved Drug Products in ANDA Submissions	James Hanratty DPD \| OGDP \| OGD \| CDER Timothy Kim DLRS \| OGDP \| OGD \| CDER
Orange Book: Looking Towards the Future	Kendra Stewart DLRS \| OGDP \| OGD \| CDER
Closing Remarks	Maryll Toufanian Director, OGDP

Agenda

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ABOUT

In the first-ever Orange Book Conference, FDA will showcase the Orange Book and provide a roadmap for the rich information it contains. This conference is a great opportunity for the brand and generic drug industries, and other interested public health stakeholders, to hear from the agency’s Orange Book experts, and provide feedback on its use and functionality.

LEARNING OBJECTIVES

After this conference, participants will be able to…

Identify and use the various types of information in the Orange Book, including therapeutic equivalence ratings, patents, exclusivities, and more.
Describe the origin and history of the Orange Book.
List possible future Orange Book enhancements.

Topics

History of the Orange Book
Orange Book 101
Updates to Orange Book Information
Orange Book Content
Patent Information in the Orange Book
Best Practices for 505(b)(2) and ANDA Applicants
Exclusivity Information in the Orange Book
Therapeutic Equivalence

FDA KEYNOTE SPEAKER ADDRESS

The Future of the Orange Book

Sally Choe, PhD
Director
Office of Generic Drugs (OGD) | CDER | FDA

INTENDED AUDIENCE

Representatives of companies working on, and/or who hold approved ANDAs, and/or NDAs
Consultants serving above companies
Healthcare professionals and pharmacists who work with patients to select and identify therapeutic equivalents
Academics

FDA RESOURCES

Recent Orange Book publications include:

The agency opened a public docket to solicit comments on how stakeholders and the public use the Orange Book and whether and how it can be improved.
The agency opened a public docket to solicit comments on the listing of patent information in the Orange Book.
In May 2020, the FDA published a draft guidance for industry, Orange Book Questions and Answers, to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book, and provide answers to commonly asked questions.

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
This conference has been approved for continuing medical, pharmacy and nursing education units. Please see detailed announcement.