www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Drug Topics: Orange Book: Frequently Asked Questions and Answers
November 16, 2020
FDA
Activity Coordinator:
Lesley Navin (Lesley.Navin@fda.hhs.gov),  Kimberly DeFronzo (Kimberly.Defronzo@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Thanh Tam Nguyen-Chu (thanh.nguyen-chu@fda.hhs.gov), 
 
Series Description

This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety.


Lecture Description
This webinar is intended to assist stakeholders in utilizing the Orange Book. It will address some of the most frequently asked questions that the FDA has received from interested parties regarding the Orange Book.
References
  • Orange Book Questions and Answers Draft Guidance for Industry (May 2020) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and- answers-guidance-industry)
  • Orange Book (www.fda.gov/OrangeBook)
  • Orange Book Preface (https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface)
  • Additional Orange Book References (https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalen ce-evaluations-orange-book)
Series Objectives
  • Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives After completion of this activity, the participant will be able to:
  • Utilize the Orange Book to identify therapeutically equivalent products
  • Identify the regulatory requirements for submission of patent information to the FDA
  • Recognize the statutory requirements for the movement of drug products between the active and discontinued sections of the Orange Book and the timing for publication
  • Employ the Orange book website to locate relevant regulatory information
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, CPH - Certified Public Health, and physician assistants.
Agenda

Lecture 1 November 16, 2020
Time Topic Speaker
1:00 - 2:00 PM Orange Book: Frequently Asked Questions and Answers Kendra Stewart
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 1 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 1.00 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 JA0002895-0000-20-006-L04-P, and ACPE Universal Activity Number JA0002895-0000-20-006-L04-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, 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, physician assistants, 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
  • Stewart, Kendra, Supervisor, Orange Book, CDER - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose
  • DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose
  • Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
  • Nguyen-Chu, Thanh Tam, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose

CE Consultation and Accreditation Team
  • Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
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