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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
October 27 - 28, 2020
Webcast

Activity Coordinator:
Lisa Misevicz (Lisa.Misevicz@fda.hhs.gov)
Description

Learners will go in-depth into FDA's Orange Book and generics. Healthcare professionals will discover how Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness.

References
  • Draft guidance for industry, Orange Book Questions and Answers https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and-answers-guidance-industry
  • Orange Book https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
Learning Objectives
  • 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.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 October 27, 2020
Time Topic Speaker
8:30 - 8:45 AM EDT Overview Brenda Stodart, PharmD, MS, BCGP, RAC
8:45 - 9:00 AM EDT Keynote Opening Remarks Sally Choe, PhD
9:00 - 9:45 AM EDT FDA's Orange Book: A Historical Review of 40 Years Kendra Stewart
9:45 - 10:30 AM EDT Orange Book 101: An Overview of FDA's Orange Book Camille Smith, PharmD
10:30 - 10:50 AM EDT Break
10:50 - 11:50 AM EDT How to Update Orange Book Information and Related Considerations: Marketing Status Changes: 506I reporting, Drug Shortages, and Transfer of Ownership Updates Kendra Stewart
Kun Shen, PharmD
Eunice Chung-Davies, PharmD
11:50 - 12:05 PM EDT Questions and Panel Discussion Kendra Stewart
Kun Shen, PharmD
Eunice Chung-Davies, PharmD
Elizabeth Friedman, JD
12:05 - 1:05 PM EDT Lunch
1:05 - 1:35 PM EDT An Overview of FDA's Patent Listing Process Kun Shen, PharmD
1:35 - 2:35 PM EDT Changes to Orange Book Patent Information Alicia Chen, PharmD
2:35 - 2:50 PM EDT Panel Discussion Kun Shen, PharmD
Alicia Chen, PharmD
Janice Weiner, JD, MPH
2:50 - 3:10 PM EDT Break
3:10 - 3:40 PM EDT The Patent Information Dispute Process Alicia Chen, PharmD
3:40 - 4:20 PM EDT Best Practices for 505(b)(2) and ANDA Applicants Mary Ann Holovac, R. Ph
Andrew Coogan, PharmD
4:20 - 4:40 PM EDT Panel Discussion and Closing Remarks Alicia Chen, PharmD
Mary Ann Holovac, R. Ph
Jennifer Gerton, JD
Andrew Coogan, PharmD
Day 2 October 28, 2020
Time Topic Speaker
8:45 - 9:00 AM EDT Day Two Overview Brenda Stodart, PharmD, MS, BCGP, RAC
Kendra Stewart
9:00 - 9:15 AM EDT Orange Book Exclusivity: An Introduction and Overview Truong Quach, PharmD
9:15 - 9:45 AM EDT Orange Book Exclusivity: Part I - NCE and 3-Year Nisha Shah, JD, M.Sc.
9:45 - 10:00 AM EDT Panel Discussion Alicia Chen, PharmD
Truong Quach, PharmD
Nisha Shah, JD, M.Sc.
Christopher Pruitt, JD
10:00 - 10:20 AM EDT Break
10:20 - 11:05 AM EDT Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN Kristiana Brugger, JD, LL.M.
Aaron Friedman, JD
Katherine Schumann, MS
11:05 - 11:50 AM EDT Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities Jonathan Hughes, JD
Mindy Ehrenfried, JD
11:50 - 12:05 PM EDT Panel Discussion Kristiana Brugger, JD, LL.M.
Aaron Friedman, JD
Katherine Schumann, MS
Jonathan Hughes, JD
Mindy Ehrenfried, JD
12:05 - 1:05 PM EDT Lunch
1:05 - 1:35 PM EDT Orange Book: An Overview of Therapeutic Equivalence Elizabeth Friedman, JD
1:35 - 1:50 PM EDT Panel Discussion Kendra Stewart
Elizabeth Friedman, JD
James Myers, JD
1:50 - 2:35 PM EDT Referencing Approved Drug Products in ANDA Submissions JAMES HANRATTY, JD
Timothy Kim, PharmD
2:35 - 2:50 PM EDT Panel Discussion Kendra Stewart
JAMES HANRATTY, JD
Timothy Kim, PharmD
Susan Levine, JD
2:50 - 3:10 PM EDT Break
3:10 - 3:40 PM EDT Orange Book: Looking Towards the Future Kendra Stewart
3:40 - 3:50 PM EDT Closing Review Kendra Stewart
Maryll Toufanian, JD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 11.75 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 11.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-20-097-L04-P for 11.75 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 11.75 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Brugger, Kristiana, JD, LL.M., Regulatory Counsel, Office of Regulatory Policy, CDER, FDA - nothing to disclose
  • Chen, Alicia, PharmD, Deputy Director, FDA - nothing to disclose
  • Choe, Sally, PhD, Director, FDA/CDER/OGD - nothing to disclose
  • Chung-Davies, Eunice, PharmD, Pharmacist, FDA - nothing to disclose
  • Coogan, Andrew, PharmD, Pharmacist, FDA - nothing to disclose
  • Ehrenfried, Mindy, JD, Regulatory Counsel, FDA-CDER-OGD - nothing to disclose
  • Friedman, Aaron, JD, Senior Regulatory Counsel, FDA/OCPP/OOPD - nothing to disclose
  • Friedman, Elizabeth, JD, Regulatory Counsel, Office of Pharmaceutical Quality - nothing to disclose
  • Gerton, Jennifer, JD, Associate Chief Counsel, Office of the Chief Counsel - nothing to disclose
  • HANRATTY, JAMES, JD, Regulatory Counsel, CDER, Office of Generic Drugs, Division of Policy Development - nothing to disclose
  • Holovac, Mary Ann, R. Ph, Clinical Analyst, FDA/CDER - nothing to disclose
  • Hughes, Jonathan, JD, Regulatory Counsel, FDA/CDER/OGD/OGDP - nothing to disclose
  • Kim, Timothy, PharmD, Division Director, FDA I received Other - PRN hourly wage from George Washington University Hospital for a role as Employee.
  • Levine, Susan, JD, Deputy Director, Division of Policy Development, Office of Generic Drug Policy - nothing to disclose
  • Myers, James, JD, Associate Director for Policy, FDA, CBER - nothing to disclose
  • Pruitt, Christopher, JD, Director, Division of Legal and Regulatory Support, Office of Generic Drug Policy My spouse received Salary from Adventist Health Care, Gaithersburg, MD for a role as Employee.
  • Quach, Truong, PharmD, Pharmacist, FDA - nothing to disclose
  • Schumann, Katherine, MS, Deputy Director, Division of Regulatory Policy, Office of New Drug Policy - nothing to disclose
  • Shah, Nisha, JD, M.Sc., Senior Regulatory Counsel, U.S. Food and Drug Administration, Center for Drug Evaluation and Research - nothing to disclose
  • Shen, Kun, PharmD, Pharmacist, FDA/CDER/OGD/OGDP/DLRS - nothing to disclose
  • Smith, Camille, PharmD, Pharmacist, FDA - nothing to disclose
  • Stewart, Kendra, Supervisor, Orange Book, CDER - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
  • Toufanian, Maryll, JD, Director, Office of Generic Drug Policy, CDER Office of Generic Drugs - nothing to disclose
  • Weiner, Janice, JD, MPH, Principal Regulatory Counsel, FDA/CDER/Office of Regulatory Policy - nothing to disclose

Planning Committee
  • Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
  • Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 85% of the activity.