FDA Drug Topics: Orange Book: Frequently Asked Questions and Answers
November 16, 2020
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.
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.
- Orange Book Questions and Answers Draft Guidance for Industry (May 2020) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and- answers-guidance-industry)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)
- 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.
- 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
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, CPH - Certified Public Health, and physician assistants.
Lecture 1 November 16, 2020
|1:00 - 2:00 PM||Orange Book: Frequently Asked Questions and Answers||Kendra Stewart|
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.
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 10 weeks after the last session of the activity to obtain their CE credit.
- Stewart, Kendra, Supervisor, Orange Book, CDER - nothing to disclose
- 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 is complimentary, therefore refunds are not applicable.
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